DePuy Synthes (a member of Johnson & Johnson Family of Companies), is currently seeking a Staff Quality Engineer to join our outstanding team located in Raynham, MA!

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

In this role you will provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. You will be responsible to conduct audits for good manufacturing practices, international organization for standardization and any other applicable standards!

Key Responsibilities:

• Developing and approving validation strategies, including but not limited to IQ, OQ, PQ, TMV or Software Validation for product/process qualification.

• Partner with R&D and other multi-functional partners to ensure the accurate application of design controls, risk management and the investigation/correction of design failures/challenges of new product/process introduction.

• Champion compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements).

• Supporting internal and external audits.

• Collaborate with multi-disciplinary teams to define and implement project strategies and action plans in support of product/process transfer projects.

• Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints.

• Escalating quality issues as appropriate.

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

• Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management

• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

Qualifications

Education:

• Bachelor’s degree or University equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field is required.

Experience and Skills:

Required:

• A minimum of four (4) years of relevant Quality Engineering experience required, Medical Device, Pharmaceutical or other highly regulated industry preferred.

• Experience implementing Quality elements such as nonconformance reporting, CAPA, Audit, Root Cause Investigation, and general problem solving.

• Effectively driving and monitoring process and procedure changes.

• Trending and data analysis skills.

• Process Validation experience.

Preferred:

• Process Excellence / Six Sigma Certification or equivalent preferred.

• Experience with Electronic Quality Systems and PLM systems preferred.

Other:

• This position will be located in Raynham, MA and may require up to 10% domestic or international travel.

The anticipated base pay range for this position is $91,000.00 to $147,200.00.

– 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

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on December 11, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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.