Job Function: Quality
Job Sub Function: Supplier Quality
Job Category:Professional
All Job Posting Locations:Raynham, Massachusetts, United States of America
Job Description: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 MedTechFueled 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.
Key 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
Qualifications:Education:- A minimum of a Bachelors or equivalent university degree is required. A degree in Engineering, Life Science, or related discipline preferred
Experience & Skills:Required:- A minimum of 4 years of related experience
Preferred:- 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
Other:- This position may require up to 20% travel
- This position is not eligible for relocation
Required Skills:Preferred Skills:Analytical Reasoning, Business Behavior, Coaching, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Data Compilation, ISO 9001, Issue Escalation, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection
The anticipated base pay range for this position is :$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
