Total 34 job vacancies by Quasar Medical (singapore) Pte. Ltd.

Job Summary:

The scope of this role is to support Singapore operations (both NPI and Sustaining Engineering), develop/ transfer/ improve manufacturing processes by evaluating/ assessing product drawings/prints and manufacturing methods in all areas of Quasar Singapore.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Evaluates/improve manufacturing processes through designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
• Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
• Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Improve manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Lead and drive process qualifications and validations including equipment qualification and material specifications.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analysing, and summarizing information and trends.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Maintain and comply with EHS, ISO13485, GMP, FDA regulations and GDP requirements

Job Summary:

This is an entry-level position within HR and General Administration department of Quasar Medical Singapore. The incumbent will be responsible to provide administrative support and assists with day-to-day operations of Human Resources department and other departments as assigned.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

HR Support

• Maintain employee records in both soft and hard copy formats.
• Process employee requests and provide relevant information and employment letters.
• Manage work pass-related activities such as applications, cancellations, renewals, six-monthly medical tests, MOM surveys, and security bond management.
• Handle employee requests on HR matters.
• Support and coordinate training programs.
• Assist in organizing and supporting site recreational activities.
• Perform other tasks as assigned by the HR manager.

Site Administration

• Keep an inventory of office supplies and manage the ordering of stationery and birthday vouchers.
• Manage the coffee machine.
• Arrange food and transportation for visitors and events or any other adhoc purchase activities.
• Maintain worker lockers.
• Schedule meetings and send invitations to attendees.
• Manage facility access and visitor management systems.
• Handle business travel arrangements, including transportation, accommodation, and ticketing.
• Prepare access cards and manage name cards.
• Perform other tasks as assigned by the site leader and supervisor

Job Summary:

Comply with the management regulation of company and department, working according to MPI’s, QI’s and other WI’s strictly.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Responsible for the safe operations of equipment to manufacture products. Perform checks and ensure safety features (machine guarding, interlocks, etc) is in place and under any circumstances should not bypass.
• Maintain 6S in working area. Follow standard
• Report immediately to direct supervisor if any safety features (machine guarding, interlocks, etc) are not functional or present some alteration.
• Comply with the management regulation of company and department, obey the job assignment.
• Operation must be conducted according to WI strictly，and familiar with their related responsibility
• Deal with other assignments assigned by superior.

Job Summary:

The scope of this role is to support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore. Develop, improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
• Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
• Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analysing, and summarizing information and trends.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Oversee and drive Validation Activities.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• Availability to travel to sending site for duration of onsite training
• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques.
• Knowledgeable in defining process capabilities and control charting.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
• Self-motivated and driver of change and innovation.
• Must be willing to work in a fast-paced environment with minimum supervision.

JOB SUMMARY:

The Quality Engineer is responsible for the product quality activities within Quasar Medical Singapore Operations. This will include support for new product development and transfers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

• Maintain and comply with the requirements of ISO13485, GMP, FDA 21 CFR Part 820 and other applicable regulations.
• Participate in the internal and notified body audit programs as required.
• Management of MRR activities.
• Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections,
• Ensure that non-conforming products are properly handled via Non-Conforming Materials Review (NCMR) process.
• Establishing inspection standards, plans, frequencies and test methods.
• Lead and drive QA initiatives across the product areas.
• Support and drive cost improvement project
• Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence.
• Drives robust and effective corrective and preventive action programs through the CAPA system.
• Strategically lead new product introduction from a QA perspective.
• Overall responsibility for production GMP standards and compliance, also including cleanroom requirements.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support Production on all quality-related activities, including working closely with Engineering and other applicable functions.
• Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner.
• Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions.
• Supervision and direction of other Quality personnel.
• To support audits from customers and external regulatory agencies (FDA, BSI etc)
• Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.

EDUCATION/ EXPERIENCE AND QUALIFICATIONS:

• Degree in Engineering or equivalent, with 3 - 5 yrs of progressive Quality responsibility, preferably in medical device manufacturing. Diploma holders in Engineering or equivalent with >5 years' relevant experience may be considered
• Excellent communication & project management skills.
• Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc.
• Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
• Knowledge of ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives.
• Proven abilities in decision making and sound personal judgement. Good organization, supervisory and investigation skills are required.
• Proven ability to influence.

WORK ENVIRONMENT:

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.

JOB SUMMARY:

Directly responsible for a team of technical personnel providing a professional level of technical support, innovation, direction and leadership.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

• Responsible for managing the Engineering Team and developing them to meet the challenging requirements of the Medical Device Industry. Ensure a data driven, innovative culture and effective problem-solving approach.
• Drive improvement in equipment and facilities performance in a sustainable and methodical manner.
• Manage a diverse array of Engineering related projects. Manage safety systems and processes.
• Effectively manage the execution of engineering to deliver yield, NPI, cycle time and efficiency goals.
• Ensure the execution of Lean manufacturing Principles throughout the plant.
• Drive Engineering based Value Improvement and Cost Reduction projects.
• Ensure that the group has a balanced skill-set of effective problem solvers, specialists and experience.
• Liaise with all other departments and functions to ensure all Engineering expectations are met and delivered on time.
• Proactively take independent action to resolve issues and improve existing processes.
• Manage capital projects to ensure compliance, on time delivery, within budget and meeting specification with minimum disruption to business operations.
• Plan, organise, direct and control project activities and resources to meet defined project, site and engineering objectives.
• Develop Engineering staff (i.e. continuing professional development).

MANAGER RESPONSIBILITIES

• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Ensure environmental aspect and safety hazard risk assessments are identified, reviewed, carried out to remove or control the risks to their respective staff at the workplace.
• Approve department environmental aspect, Risk Assessment and Safe Work Procedure if the risk is within acceptable level.
• Provide and maintain a work environment which is safe and without risk to health for employees at work.
• Report immediately all occupational accidents & incidents to the company and relevant parties and support the EHS Committee Management Representative in conduct of incident/accident investigation as appropriate.
• Initiate and/or approve disposition actions for EHS nonconformance as well as corrective/preventive actions to prevent recurrences
• Ensure that environmental, health & safety policies are upheld, EHS objectives and metrics are monitored, corrective/ preventive actions taken on EHS system defects are effective and properly closed.
• Responsible for the safety, health and well-being of workers under their charge.
• Provide support in EHS internal and external audits.

MANAGER AUTHORITIES

• To enforce compliance to company’s EHS management system and relevant legal and other applicable EHS requirements.
• To delegate task/s to his/her subordinates.
• To stop any unsafe work or negligent act that may endanger personnel.
• To investigate and analyse any incidents that occurred within his/her charge

Education/Experience and Qualifications

Degree in Engineering (or equivalent experience) and at least 10 years management experience with 4 – 5 years in a medical device manufacturing environment;

• Must have at least 3 – 4 years of experience in balloon catheter manufacturing and engineering;
• Demonstrated proficiency utilizing engineering tools (i.e. FMEA, DOE, SPC, statistical tools, etc.);
• Knowledge of GMPs, ISO 9001/EN 46001, ISO13485 and the Medical Device Directives;
• Prior manufacturing and product transfer experience;
• Preferably, Certified Six Sigma Green / Black Belt;
• Possess good coaching/mentoring skills;
• Excellent communication skills and have demonstrated the ability to lead in a previous role;
• Experience in people management and development with strong team building skills with proven abilities in decision making and sound personal judgements;
• Have the ability to implement Process Capability and Lean Principles in every aspect of Engineering. Knowledge of ISO and FDA compliance a definite advantage;
• Computer literate in Microsoft Office applications.

Work Environment

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Controlled Environment (Class 100K cleanroom) and office area.

JOB SUMMARY:

A material handler maintains distribution of materials to production floor by kitting jobs in accordance with the material requirement per stated in the Bill of Materials (BOM).

ESSENTIAL DUTIES AND RESPONSIBILITIES: Include the following. Other duties may be assigned.

· Ensure kitted jobs release to production are correct such as part numbers and material requirement as stated in the job router.

· Follow and observe proper FIFO (First In First Out) of materials.

· Maintain proper material labelling and stocks recording.

· Ensure actual quantity and ERP system are tally and accurate.

· Ensure kitted jobs and released to production on time.

· Perform material transactions on timely manner.

· Use any safety features (machine guarding, interlocks, etc.) in place at respective machine in use and under any circumstances should not bypass.

· Report immediately to direct supervisor if any safety features (machine guarding, interlocks, etc.) are not functional or present some alteration.

· Perform cut to length process in accordance with the Manufacturing Process Instruction (MPI) and SA0379 document.

· Keep records for the kitted jobs for future reference and easy traceability.

· Perform line clearance and ensure cleanliness of kitting room.

· Maintain and comply with ISO 13485, GMP and FDA regulations.

JOB SUMMARY:

Responsible to maintain Product Quality within Quasar Medical, Singapore Operations. This will include support for new product development and transfers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

· Maintain the requirements of IS013485, GMP, FDA 820 and other applicable regulations.

· Participate in the internal and external audit programs as required.

· Supporting NC, CAPA, customer complaint activities.

· Preparing document related to product specifications, test methods, processes, validations etc.

· Supporting the data analysis process during validation.

· Responsible for the management of the equipment calibration in Quasar Medical Singapore.

· Participate in QA initiatives or cost improvement project

· Participate in new product introductions

· Other tasks assigned

JOB SUMMARY:

The Senior Microbiologist is responsible for activities on environment control, hygiene practice, sterilization and microbiological relevant matters within Quasar Medical Singapore Operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

· Maintain and comply with the requirements of ISO13485, GMP, FDA 21 CFR Part 820 and other applicable regulations.

· Participate in the internal and notified body audit programs as required.

· Management of MRR activities.

· Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections,

· Ensure that non-conforming products are properly handled.

· Establishing inspection standards, plans, frequencies and test methods.

· Lead and drive QA initiatives across the product areas.

· Support and drive cost improvement project

· Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence.

· Drives robust and effective corrective and preventive action programs through the CAPA system.

· Strategically lead new product introduction from a QA perspective.

· Overall responsibility for production GMP standards and compliance, also including cleanroom requirements.

· Participate in new product introductions to ensure quality is built into all products early in their life cycle

· Support Production on all quality-related activities, including working closely with Engineering and other applicable functions.

· Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner.

· Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions.

· Supervision and direction of other Quality personnel.

· To support audits from customers and external regulatory agencies (FDA, BSI etc)

· Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.

SUPERVISORY RESPONSIBILITIES:

Other Quality personnel where required.

EDUCATION/ EXPERIENCE AND QUALIFICATIONS:

· Degree in Engineering or equivalent, with 3 - 5 yrs of progressive Quality responsibility, preferably in medical device manufacturing. Diploma holders in Engineering or equivalent with >5 years' relevant experience may be considered

· Excellent communication & project management skills.

· Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc.

· Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.

· Knowledge of ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives.

· Proven abilities in decision making and sound personal judgement. Good organization, supervisory and investigation skills are required.

· Proven ability to influence.

WORK ENVIRONMENT:

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.