Johnson & Johnson Careers
Lead Quality Engineer
Requisition ID: 1805651351W
The Staff Quality Engineer will provide quality engineering expertise and quality oversight as the Franchise Management Representative for the Innomedic product development site. Specifically, leading execution of quality processes, including Corrective and Preventive Action (CAPA), Non-Conformances (NC), New Product Development, Management Review, and Quality metric reporting for the Trauma franchise locations in Zuchwil, Switzerland and Philippsburg, Germany.
Working in a fast-paced design team setting at Innomedic, this individual is designated as the Management Representative and has the following responsibilities (but not limited to):
- Provide leadership in all areas of the Quality Management System (QSM), including, but not limited to Audit Management, CAPA, Complaints, Post Market Surveillance, NC, Risk Management, etc.
- Enhance the related processes to reflect regulatory requirements, state of the art practices and drive continuous improvement.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Diligently participate in compliance program-related activities
- Work closely with suppliers on the qualification of new processes supporting software development.
- Conduct assessments of new suppliers as required as a part of a project team
- Know and follows all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
The Staff Quality Engineer will provide quality engineering oversight and execution guidance for both Innomedic and Zuchwil sites. Areas to support will include:
- Collaborate with representatives from other functional areas to facilitate timely and effective investigations, action implementation and effectiveness monitoring in support of CAPA/NC processes.
- Collaborate with representatives from other functional areas in the compilation of data and commentary to support the management review process.
- Serve as a CAPA/NC Subject Matter Expert (SME). Monitor, analyze, and report QMS metrics.
- As Franchise site Management Representative provide audit management support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits)
- Provide training regarding CAPA/NC/QMS elements to representatives from other functional areas.
- Identify opportunities to continuously improve quality processes in alignment with overall quality and business objectives, as well as taking ownership of CAPAs, as needed.
- Support and participate in cross-functional projects when assigned, will facilitate technical innovations to enhance processes and support business goals, and will assist with other related activities as requested by management.
- Coordinate collection of data, schedule and conduct management review meetings, confirm training for required attendees, and disseminate presentations/meeting minutes in support of management review.
- A minimum of a Bachelor’s Degree is required. A degree concentration in Computer Science, Engineering or equivalent studies is preferred.
- A minimum of 5 years of experience in Quality and/or Compliance within the Medical Device Industry and/or Pharmaceutical Industry is required.
- Specific experience in corrective and preventive action efforts is required.
- Strong understanding of all regulations and normative requirements regarding Medical Device Industry (21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971 FDA QSR is required).
- Business fluent in English and good knowledge of German.
- Experience with audit management is strongly preferred.
This position required travel to our Innomedic site in Germany at least 1 week out of each month.
Synthes GmbH (7111)