Sr Supplier Quality Engineer

Johnson & Johnson Innovative Medicine • Raynham, MA

3d • $79,000 - $127,650 • Onsite

About The Position

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. DePuy Synthes Companies is recruiting for a Sr Supplier Quality Engineer to be located in Raynham, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Sr Supplier Quality Engineer will provide comprehensive product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes for the DePuy Synthes business.

Requirements

• A minimum of a Bachelors or equivalent university degree is required.
• A degree in Engineering, Life Science, or related discipline preferred
• A minimum of 4 years of related experience
• Experience in the Medical Device industry
• Experience in Operations or Source Quality
• ISO regulations knowledge
• FDA CFR Part 820 and ISO 13485 knowledge
• Auditing background
• Strong communication, partnership, and analytical skills
• Strong in root cause analysis skills
• Experience with process validation
• Experience or knowledge with machining manufacturing processes, injection molding and/or electronics manufacturing
• Six Sigma, Lean, or ASQ Certification and training

Responsibilities

• Provides quality engineering leadership in the management of select contract manufacturing and supplier sites engaged in the production and delivery of Johnson and Johnson products and services
• Responsible for technical leadership in establishing quality expectations at the supplier, to include process changes in partnership with Source Quality and New Product Development (NPD) Teams
• Partner with NPD team to support successful launches at suppliers
• Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO and other applicable standards
• Provide product team support for quality system requirements and supplier auditing, compliance assessment, and support of sustaining manufacturing processes
• Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management
• Address and support investigation of product issues to include product and processing complaints
• Apply industry and process excellence tools and standards in daily quality operation activities, to include Good Manufacturing Practices (GMP), equipment engineering system (EES), and ISO
• Report on supplier performance metrics during quality and management reviews
• Lead supplier visits to assess compliance to process excellence standards
• Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability.
• Identify, bracket, correct and prevent defects.
• Present reports to management
• Evaluate and implement improved manufacturing engineering performance management systems and tracking tools, as well as facilitating resolution of complex technical, quality and operational problems

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior