Manager, Quality Assurance Planning

Manager, Quality Assurance Planning

As one of the world´s leading manufacturers of cardio
- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

**Your Responsibilities**
- Provide leadership and direction to the Quality Assurance team in supporting R&D on risk assessments, transfer projects, and product development. Ensure quality assurance compliance with established procedures, design rules, standards, and regulatory requirements.
- Serve as the Quality Assurance Planning team lead for new product development, risk assessments, and transfer projects, representing the Quality function in cross-functional teams.
- Ensure all design control and production transfer projects comply with local and international regulatory requirements, as well as site and business-specific standards.
- Develop quality plans for new products, collaborate on the design of inspection and testing activities, and work closely with Quality Assurance Operations to ensure seamless transfer of quality requirements.
- Promote the use of statistical methods for quality testing and control during development or transfer, ensuring data-driven decision-making.
- Provide technical quality support to the business development units, addressing quality-related concerns and ensuring alignment with business goals.
- Contribute to the assembly and maintenance of Design History Files (DHF) to ensure comprehensive documentation throughout the product lifecycle.
- Ensure design and development documentation adheres to ISO 13485/FDA QSR Quality System requirements, maintaining compliance with industry standards.
- Create and maintain controlled documents (e.g., SOPs, Specifications, Methods) to ensure strict compliance of development process accordance to ISO 13485/FDA QSR Quality Systems.
- Champion investigations of non-conformities during transfer, conducting risk assessments, and initiating corrective/preventive actions that ensure reliability and compliance with quality standards.
- Review and approve methods and procedures to evaluate, measure, control, and monitor products or processes, ensuring compliance with design for manufacturing and transfer requirements. Approve analytical test data, ensuring accuracy and the appropriate use of statistical tools and sampling techniques.
- Review and approve product and process change requests from development engineering teams. Ensure engineering reports are technically sound, risk-assessed, and aligned with quality engineering specifications and requirements.
- Delegate Quality representative in product development and transfer activities, fostering collaboration within engineering, operations, and cross-functional teams. Ensure alignment on product transfer qualification, specification alignment, and process validation plans/execution.
- Provide guidance, coaching, and support to the Quality Assurance Planning team on their responsibilities, project assignments, improvement initiatives, and quality activities.
- Offer leadership and performance coaching to direct reports, conducting performance assessments, and establishing individual development plans to foster growth and accountability.
- Support and execute quality-related projects and other activities as directed by the supervisor.

**Y**our Profile**
- Technical / scientific degree at college / university level (mechanical, biomedical, polymer engineer-ing, natural sciences)
- At least 10 years’ work experience in a quality engineering/operations function in regulated environment (medical devices industry)
- At least 3 years of managerial experience in leading a team
- Quality inspections, measurement techniques and experiences in failure analysis
- Comprehending technical drawings and specifications
- Experience in aseptic environment, cleaning, and hygiene regulations
- Knowledge in process validation and computer system validation
- Continuous Improvement (CI) experience will be preferred
- Trained in six sigma or lean manufacturing will be preferred
- Project management/ transfer experience will be preferred
- cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC, MDR EU 2017/745
- Preferred ISO 13485 Lead auditor / knowledge in FDA inspection
- Statistical and Analytical methods
- SAP (Manufacturing Execution Systems / MES will be an advantage)

**What we offer**
- being encouraged to think and act entrepreneurially.
- working in global teams and projects.
- developing yourself professionally.

Location: Singapore | Working hours: Full-time

Job ID: 61242 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orient