- Entry level
- No Education
- Salary to negotiate
- West Chester
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Supplier Quality Engineer located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
You, the Senior Supplier Quality Engineer (SQE) provides overall quality assurance and quality engineering leadership in the management of contract manufacturing suppliers, including Finished Good Medical Devices, Direct and Indirect Material/Service Suppliers which can impact Johnson and Johnson production and/or sale of J&J product. This Sr. SQE will also be responsible for management and strategic direction and solution for the DePuy Synthes Approved Supplier List. In addition, there will be several key projects assigned to the candidate selected for this role.
You, the Senior Supplier Quality Engineer will conduct day-to-day and strategic activities in the lifecycle management of suppliers. As a Sr. SQE, you will establish clear expectations and collaborates with internal and external partners that lead to consistent, reliable, quality products and services.
Activities include but are not limited to:
Manage the Approved Supplier List for the franchise
The selection, categorization and qualification of suppliers and associated processes
Adding, removing and updating quality system supplier information while ensuring accurate supplier information on the Approved Supplier List.
Establishing and providing relevant information detailed in quality and change agreements.
Executing and documenting supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs).
You will define, and lead actions related with Supplier Change Requests.
Leading and supporting supplier assessments and audits for compliance to regulations, agreements, standards and documented processes.
Guide the development and improve comprehensive measurement systems for the SQ program and supplier quality performance. The individual may report on such metrics at Quality System management reviews.
Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects
Leading and documenting internal supplier quality procedure change efforts. The individual will adhere/comply with and utilize multifaceted industry and process excellence standards on an expert level, including good manufacturing practices (GMP), equipment engineering system (EES), international organization for standardization (ISO) and country/governmental regulations. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
Support local plant/facility-based initiatives and projects.
A Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
You will have a minimum of 4 years of experience in a GMP and/or ISO regulated industry. Experience in the medical device and/or pharmaceutical industry is preferred.
You are knowledgeable in FDA and ISO regulations is required. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
Auditing background is preferred.
Strong communication, partnership, and analytical skills are required.
You have strong root cause analysis skills.
Experience and/or knowledge with machining manufacturing processes and injection molding is preferred.
An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
Prior project management experience is preferred.
You have experience with CNC Milling and Turning; Press Breaking and Punching, Assembly; Metal Laser Etch; Silk-Screen, and Metal Processing such as passivating anodizing and heat treating preferred.
The position may require up to 15% domestic/international
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.