DePuy Synthes is recruiting for a Quality Operations Leader, to be 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 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. The Quality Manager plans, directs, and conducts projects of major scope and significance to the Company with full technical responsibility for interpreting, organizing, executing and coordinating assignments. They may contribute inventions, new designs or techniques which are materially significant in the solution of important problems. Quality Engineering Manager will act as a mentor to more junior staff and advice top management on technical matters. The Quality Manager will apply Quality Engineering tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also apply Quality Engineering principles and problem- solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. They will ensure effective risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in Base Business and supervise, lead and mentor other engineers and technicians across the site. Key Responsibilities: Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Leads or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Establish and maintain department/cost center budget
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians) across multiple sites and/or various geographic regions.
- Lead and maintain Material Review Board.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Collaborates with other quality leaders to identify required quality engineering skills and competencies to allow for the execution of the strategic vision.
- Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
Education: - University/Bachelor of Science or equivalent degree is required.
Experience and Skills Required: - Six to eight (6-8) years of related experience.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards).
- Experience with a proven track record of implementing appropriate risk mitigation.
- The ability to perform hands on troubleshooting and problem solving is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise.
- Excellent technical understanding of manufacturing equipment and processes.
- Strong mentoring, coaching and leadership skills.
- Experience in supervising and directing the work of others.
- Ability to manage resources remotely.
- Advanced knowledge and proven leadership in the areas listed in the duties and responsibilities associated with the position.
- Demonstrated project management and project leadership abilities.
- This position will require relevant experience working in Manufacturing/Operations.
Preferred: - Experience working in both an FDA and European regulatory environment.
- The ability to think on the feet and provide sound judgment is highly desired.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- A thorough understanding of GMP/ISO regulations and validation regulations.
- Experience in more than one of the following preferred (cross-sector): Consumer Products, Medical Devices and Diagnostics, Pharmaceuticals.
- Experience in Medical Device Products, Consumer Health, or Pharmaceuticals.
- Experience with sterile devices or sterilization processes.
- Experience in Quality & Compliance, Supply Chain, Commercial, and/or R&D.
- Experience with Six Sigma/Process Excellence tools, training and certification.
- Organizational change management experience.
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 .