At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies and is recruiting for a Source Quality Engineer III located in Raynham, MA!

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 Source Quality Engineer III 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 for 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
• Evaluating and implementing 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 bachelor’s degree is required. A degree in Engineering, Life Science, or related discipline preferred

Experience and Skills:

Required:

• A minimum of 4 years of experience
• Experience in the Medical Device industry
• Experience in Operations or Source Quality
• ISO regulations knowledge
• FDA CFR Part 820 and ISO 13485 knowledge

Preferred:

• 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 is anticipated to have up to 10% travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Please visit www.careers.jnj.com.

The anticipated base pay range for this position is :

$77,000- $124,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.