Danaher Corporation QA Senior Specialist – Release Control at supplier (Release Person) in Shanghai, China
I. GENERAL SUMMARY & OVERALL CHALLENGES The QA team has a significant role in securing reliable and compliant products due to his/her compliance and process knowledge, during production, storage and shipping of supplier manufactured products. This is done by cooperating, supporting, facilitating, training and communicating towards obtaining the best results with partners in Supply Chain, Operations, Warehousing and supporting functions at the Production location in Suzhou and the other locations World Wide.
The position is located in Suzhou and reports to Senior Quality Manager, QA, Supplier Quality Management (located in Copenhagen HC), as part of QA Quality team.
Key ResponsibilitiesHave an active role within part- & component release by supporting the outgoing inspection at the critical suppliers, assure all the Radiometer requirements are met before parts are shipped out. Both dimensions, verification test, monitoring & correct storage of data.
Have an active role within supplier enabling/development to assure the known tools within continuous improvement are implemented at supplier.
Ensures compliance to regulatory requirements for Supplier Quality Management in corporation with Procurement and Supplier teams in Manufacturing, as part of the Global SQM team.
Assures the global QA SQM process to approve and monitor suppliers in close corporation with Procurement and the global SQM-team.
Understands how QA processes supports and impact the business.
Responsibilities • Drive the verification process at supplier:o Assurance fulfilment Radiometer requirements within outgoing inspectiono Detect the weaknesses at supplier & assure the continuous improvement at supplier. By using the well-known tools within the industry.• Partner with Procurement, Production, R&D to ensure continuous compliance to ISO 13485:2016 requirements and other relevant regulations and ensure efficient QA processes.• Drive global QA SQM activities within your area of responsibility: o Approval and evaluation of suppliers.o Establish and maintaining Quality Agreements with Contract Manufacturers and Suppliers.o Be part of Supplier audit team and perform Supplier Audits as lead auditoro Participate in Supplier Quality Management team meetings.o Support the World Wide organization with supplier actions within your area of responsibility.o Assurance outgoing inspection at supplier• Collaborating closely with Operations management to ensure timely and compliant product deliveries.• Use a lean process view to constantly improve quality processes to become efficient, lean and in compliance with regulations.• Participating in quality training activities towards suppliers.• Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.• Providing guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
II. REQUIREMENTS FOR THIS POSITIONa) Position Specific Competencies / Experience
• Knowledge regards the quality tools:o Quality Problem detection at supplier (KPI-set-up, Quality Data Collection)o Quality Problem Solving (NCR-handling, 8D, 5xwhy, Ishikawa, Pareto)o Quality Problem Prevention (Quality Assurance Matrix, Layered Process Audit)o Quality Awareness Gene (5S, VSM & VSD, Fast Response)o Continuous Quality Improvement (Kaizen)• Power and drive to ensure execution and results.• Negotiation and change management skills.• Presentation skills to all levels of the organization.• Minimum 5 years experience with Supplier Quality Management within Medical Devices or Pharma.• Experience and practical knowledge about quality assurance for medical device products and components• Broad process knowledge (production as well as R&D experience) preferred.• Experience with performing Quality Agreements and Supplier Audits• Knowledge of regulatory demands and standards: GMP, FDA legislation, MDR, IVDR, MDSAP is an advantage• Work Experience from other Medical Devices or IVD companies in a similar role• Lead Auditor certificate in ISO 13485:2016 is preferred.• Able to keep the overview in situations that requires quick decisions with a holistic view on Quality and Delivery.
The ideal candidate holds a M.Sc. or B.Sc. degree in engineering or has Pharmaceutical background. However, if the candidate has a good technical understanding and is able to learn the technical aspects of the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted
Chinese and English fluently in writing and speaking
A good working knowledge of modern IT tools
e) Travel (required estimated % of time)
According to projects, but probably in the level of 20% a year
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .