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.