Supplier Quality Engineer

Supplier Quality Engineer

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.

The Engineer, Supplier Quality (SQE) is responsible for Supplier Quality management. The role will be supporting and driving compliance/continuous improvements of Suppliers and quality performance of the materials received. He/She shall be responsible to drive supplier quality management process collaboration with the relevant team members of departments/functions, for alignment and drive consistency on supplier quality management process/activities execution.

**Your Responsibilities**:

- Coordinate and setup Incoming material inspection process, for new project development to drive for ensuring materials conformance to specifications and meet all manufacturing requirements. Develop inspection plans, advanced analytic/metrology tools and/or criteria for incoming material inspection.
- To resolve supplier related quality issues to ensure timely & effective resolution and continuity of supply. Proactively work with suppliers to identify improvement opportunities, controls and continually improve the received materials quality level.
- Maintain the Supplier Quality management, including quality reports, Supplier Assessment-Qualification, SCAR, Supplier change notification, 1st article approval, supplier scorecards and supplier development plan.
- Support supplier related change request and qualification initiatives (i.e. new parts, new revision, new tooling).
- Review and approve suppliers’ control plans and inspection standards.
- To ensure Incoming materials are processed in a timely manner through QA location. Manage and ensure timely and effective inspection of incoming materials.
- Manage the Non-Conforming Material for incoming materials, and materials related to rejection.
- To monitor aging period for non-conforming incoming materials.
- To ensure supplier quality issues are resolved in a timely manner, including Corrective Actions.
- Drive measurable improvement projects to ensure supplier performance continually and consistently excel in their scorecards.
- To ensure all Supplier Quality Agreement are established and maintained.
- To maintain and lead the Supplier Audit (desktop/remote/onsite) program. Develop supplier audit schedule, and perform audit on suppliers periodically to ensure compliance to standards.
- Drive productivity improvement projects for incoming section.
- To develop and manage a team of Incoming QA inspectors/technician.
- To provide key performance metrics updates to management.
- Support and Execute projects/task and any others quality related activities as directed by supervisor.

**Your Profile**
- Technical / scientific degree at college / university level (mechanical, biomedical, polymer engineer-ing, natural sciences)
- At least five years’ work experience in a quality function in regulated environment (medical devices/life science/pharmaceutical industry)
- In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations
- ISO 13485 auditor experiences or certification
- The ability to foster a productive team-oriented environment, handling multiple assignments, and flexibility in responding to an environment with rapidly priorities shifting/changes is preferred
- Well-developed problem solving skills, excellent verbal and written communication skills, and the ability to listen, learn, teach, and think strategically are traits that are required for long term success in this role
- Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred
- Documents and Records lifecycle management experiences, is preferred
- Good communication skills with people from all levels in the organization
- SAP and Success Factor User experience is a plus

**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: 50664 | 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 orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.