Manager, QA

About the role

Lead, manage and supervise a team of engineers to ensure the product shipped out of Tecan CDMO Solutions PN are complying to the customer's acceptance requirements. Oversee the activities of the product quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for customer products. Ensure successful product transfer and new product implementation are done according to internal procedures and regulatory requirements to ensure compliance with applicable standards and regulations. Monitor and track production output and performance to ensure consistency, conformance, and compliance.

Key responsibilities

1.      Quality Engineering

Sustaining Products:

• Updating of current inspection criteria in accordance with customer specific requirements.
• Customer communication regarding respective products
• Updating of current inspection criteria in accordance with customer specific requirements.
• Review and approval of process documentation such as control plan, FMEA, manufacturing process instructions.
• Handling of customer escalation.
• Process customers survey related to QA topics
• Engineering change management review and approval coordination.
• Review changes for revalidation. Evaluate the changes to decide extent of revalidation.

NPI:

• Coordination of new product introduction implementation for medical devices.
• Setting up of new product inspection criteria  in accordance with customer specific requirements.
• Ensure all quality requirements for new product introductions are being met. Including coordinating submissions of regulatory documents in coordination with Tecan corporate RA department
• Lead weekly call with Paramit Morgan Hill QA to obtain information regarding transfer product.
• Responsible for product design transfer review and approval.
• Draft, review, approve, guide, and also monitor the validations for process, equipment, products, building.

2.      Supplier Quality Engineering

• Oversee and manage assignment of commodities, ensuring effective collaboration with suppliers to resolve material quality issues and drive continuous improvement.
• Lead, coach, and advise the SQE team in handling material quality issues, fostering a culture of quality and accountability.
• Review and approve suppliers’ 8D reports, ensuring thorough containment, root cause analysis, corrective actions, and preventive actions are implemented.
• Direct the development, review, and amendment of forms, working instructions, and procedures to maintain and enhance quality standards.
• Supervise and mentor IQC technicians in the handling of incoming rejects, production feedback, and Final Quality Assurance (FQA) rejects, ensuring adherence to best practices.
• Plan and conduct supplier assessments and audits, evaluating supplier performance and compliance with company requirements.
• Oversee the preparation and analysis of monthly reports and supplier performance ratings, providing insights and recommendations to senior management.
• Validate and resolve production complaints, ensuring thorough investigation and implementation of corrective actions.
• Clearance of MRB high value and aging items on timely manner.
• Coordination of non-conforming reports for materials
• Ensuring zero defect escapee of the materials received from suppliers.

3.      Audit

• Supporting Regulatory audits, such as FDA, UL Inmetro & EUMDR.
• Supporting customer audits.
• Supporting certification audits (ISO 9001,13485….)
• Involved in QMS & EMS internal audits

4. Perform additional managerial duties as assigned by senior management, contributing to the overall success of the quality engineering function.

About you

• Engineering Degree required
• 8~10 year experience in Quality
• English & Bahasa Malaysia language skills
• Strong knowledge of the quality policy and procedures
• Knowledgeable in QC tools and Data Analysis
• Good QMS & EMS knowledge
• Good awareness on legal & best practices for QA
• Leadership Competencies: Decision Making, Problem Solving, Strategic Thinking, Analytical Thinking, Managing Shared Values & Critical Thinking
• Core Competencies: Communication, Teamwork, Innovative, Assertiveness, Responsible, Self-Discipline & Drive Excellence

About us

Tecan CDMO Solutions Penang is a quality-focused organization committed to ensuring products meet customer acceptance requirements and comply with applicable standards and regulations.