We are representing an MNC in the Aviation and Marine Equipment industry to hire for a Quality Assurance Manager.

Responsibilities:

• Oversee and improve the QMS to meet regulatory and audit requirements.
• Lead quality initiatives, promoting best practices across the organization.
• Perform internal and external audits, ensuring corrective actions are implemented.
• Train employees on quality systems and processes.
• Manage budgets for quality-related projects and certifications.
• Conduct incident investigations and ensure proper reporting.
• Ensure compliance with licensing and regulatory standards at key locations.
• Collaborate with teams to address non-conformance issues and follow up on supplier actions.

Skills & Requirements:

• Certified in ISO9001/ AS9100 / AS9110 with strong auditing skills.
• Familiarity with Aerospace Part 145 Requirement
• Has passed the CAAS Air Legislation examination paper M10, L11, L12
• Knowledge of industry standards and quality improvement tools (Lean, Kaizen, 5S).

Interested candidates please apply here.

EA Personnel (Koh Pei Wen)

EA Reg: R23115205

APBA TG Human Resources Pte Ltd

EA License: 14C7275

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

Quality Assurance Manager

Job Responsibilities:

Quality Assurance

· Establishment, Maintenance and Continuous Improvement of Company’s Quality Management System (QMS), Class Approvals (Marine) and Regulatory Requirements (Part 145).

· Plan, organise and take lead to drive Quality initiatives and promote quality culture within the company.

· Maintaining and continually improving quality performance, to meet the maintained or all Divisions.

· Perform all essential audits and inspecting internally and/or by third party or client as and when required.

· Establishment, implementation and co-ordination of the audit & approval program, reporting of audit outcomes and ensuring follow up of corrective actions.

· Assist department to follow up on root cause analysis and creation of appropriate action plan to prevent recurrence of issues, by providing training and guidance to the team whenever required.

· Conduct incident investigation and prepare concise investigation reports with in accordance to the regulatory requirement.

· Training and development of employees with respect to QMS and its related processes, quality principles, tools and techniques etc.

· Ensure all licensing at Singapore site and products/services are managed for new applications and renewals.

· Budget allocation and control of costs for QMS related projects; resource management; training; third party audit and Certification costs; and professional subscription costs.

• Effectively implements quality procedures for all allocated sites, in line with legislation, regulatory and guidelines. Documents and maintains the register of quality approvals, procedures and accreditations for allocated sites / geographies.

• Communicates to all allocated sites quality procedures, ensuring all relevant regional colleagues are aware of their responsibilities in supporting / upholding Quality Assurance processes.

• Manages operational, technical, health, safety and environmental audits in line with the audit calendar

• Participates in quality, non-conformance and complaint investigations, ensuring findings are documented, reported and escalated appropriately. Monitors and follows up on supplier CAPA and improvement actions

• Contributes to statistical analyses on which to base recommendations for improvement

• Advises business leaders and senior managers of compliance issues or matters requiring supplier quality development or improvement

• Any ad-hoc duties or projects as assigned.

Skills

• Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems

• Gains the confidence and trust of others through honesty, integrity, and authenticity

• Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences

• Knows the most effective and efficient processes to get things done, with a focus on continuous improvement

• Anticipates and balances the needs of multiple stakeholders

• Uses compelling arguments to gain the support and commitment of others

• Interprets and applies key financial indicators to make better business decisions.

• Plans and prioritises work to meet commitments aligned with goals.

• Operates effectively, even when things are not certain, or the way forward is not clear

• Knows the most effective and efficient processes to get things done, with a focus on continuous improvement

• Builds partnerships and works collaboratively with others to meet shared objectives

Job Requirements:

· Degree in Engineering or Quality Assurance or equivalent with at least 5 years of relevant managerial experience in marine, aviation or related Industry.

· Certified ISO9001:2015 internal/lead auditor qualification.

· Successful completion of the CAAS M10/L11/L12 Examination.

· Able to interpret CMM, in particular IPL (illustrated part listing) and special equipment and tooling listing will have added advantage.

· Preferably have experience in liaising with OEM for capability expansion.

· Certification or experience in Lean, Kaizen and 5S or familiar with common quality tools and techniques.

· Knowledge of relevant standards, and the ability to become conversant with the rules and regulations relating to the quality systems specific to the marine, defence and aviation industries;

· Experience in practical administration, maintenance and development of Quality Management Systems.

· Knowledge of the practical implementation and development of Continuous Improvement and Lean or other similar methodology in a manufacturing, engineering and/or supply chain environment.

· Good leadership and proven managerial skills to be able to lead and motivate the team.

· Meticulous, resourceful, team player and possess strong organization skills.

· Internet savvy and proficient in MS Office applications (ie. Outlook, Excel, Words and Powerpoint etc)

· Effective oral and written communication and interpersonal skills.

· The ability to plan and prioritize work and work under high pressure to tight deadlines yet flexible and adaptable to changing needs and situations.

1. Review and refining existing process flow, and process failure mode and effect analysis (FMEA)
2. Optimizing existing standard operating procedure for quality inspection, cycle time for inspection activities & calibration schedule program.
3. Data trending of quality complains & defect, NC & CAPA through use of SPC.
4. Ad-hoc activities for LHR review and documentation.