Johnson & Johnson Careers
Quality Engineering Manager
Zuchwil, Switzerland; Philippsburg-Rheinsheim, Germany
Requisition ID: 1805687999W
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings help advance the health and well-being of people around the world.
The Quality Engineering Manager will define, lead and implement state-of-the-art quality engineering expertise and quality oversight as the Franchise Management Representative for the Innomedic product development site. Specifically, leading execution of quality processes, including Audit/Inspection, 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.
Position duties & responsibilities:
- Working in a dynamic design team setting at Innomedic, you will be seen as the Management Representative and will have the following responsibilities (but not limited to):
- Provide leadership in all areas of the Quality Management System (QMS), including, but not limited to Audit/Inspection Management, CAPA, Complaints, Post Market Surveillance, NC, Risk Management, etc.
- Improve 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 follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times. The Quality Engineering Manager 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.
- You will cooperate 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 serve as audit/inspection lead for 3rd Party Audits and Inspections (e.g. Registrar, Notified Body, FDA, or customer audits)
- Provide training regarding CAPA/NC/QMS elements to representatives from other functional areas.
- Find 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 multi-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.
- Oversee collection of data, schedule and conduct management review meetings, confirm training for required attendees, and disseminate presentations/meeting minutes in support of management review.
Professional experience requirements:
- Strict attention to detail.
- Should be able to work under pressure due to reporting deadlines.
- You have to be able to work independently and prioritize with little supervision.
- Strong written/oral communication and interpersonal (listening) skills.
- Must have ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision-making.
- Minimum 4 years experience in a regulated industry (medical device or pharmaceutical). Post market regulatory, quality or compliance areas preferred.
- Analytical and critical thinking skills are important.
- Excellent interpersonal and time management skills.
- Willing to work in an international team.
- A minimum of a Bachelor’s Degree is required. A degree concentration in Computer Science, Engineering, Science or equivalent studies is preferred.
- At least 8 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.
- Experience with audit management is required.
- Experience with EtQ Instinct CAPA/NC module is preferred.
- Deep 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 basic knowledge of German.
- A certification in Process Excellence (e.g. Green Belt) is an asset.
- Proven ability to work effectively with multi-functional teams for problem-solving, product and process improvement is required.
- Organizational and communication skills providing the ability to multi-task in a fast-paced environment are required.
- This position will be based in Zuchwil, Switzerland and will require up to 25% domestic and/or international travel.
Synthes GmbH (7111)