Global Manager, LIMS

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:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
People Leader

All Job Posting Locations:
Bridgewater, Massachusetts, United States of America

Job Description:

Employer:          Medical Device Business Services, Inc.

Job Title:            Global Manager, LIMS

Job Code:           A011.4817

Job Location:     Bridgewater, MA                                                 

Job Type:            Full-Time

Rate of Pay:       $142,000 - $155,000/year

Job Duties: Support quality improvement initiatives such as process and product characterizations that lead to continuous and cost improvements.

Review and analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean techniques, and/or other improvement tools and programs.

Conduct benchmarking to develop more effective methods for improving quality.

Lead and execute Laboratory NR, CAPA, and Observations.

Support the development of quality engineering and quality compliance with the right skill sets for new product introductions and product life cycle management.

Review and analyze whether current products and processes comply with standards such as the QSRs, ISO 13485, etc.

Champion compliance with applicable global regulations and standards, including providing support during internal and external audits.

Conduct periodic line audits to assess production controls such as lot segregation.

Review results of area audits to ensure corrective and preventive actions are adequate.

Partner with R&D and other multi-functional teams to ensure the proper application of design controls, risk management, and the investigation/correction of design failures and challenges.

Support new product introduction as part of the design transfer.

Support activities related to the Material Review Board.

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

Escalate quality issues.

Take accountability and ownership for material identification, material segregation, and classification of defect types.

Analyze and review the effectiveness of preventive and corrective actions.

Review root cause investigations.

Take accountability and ownership of quality metrics, including maintenance and review of leading and lagging indicators of quality.

Document quality metrics for adequate reporting for...