Senior Quality Engineer

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 Med Tech, 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.

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Job Function

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

Location

Raynham, Massachusetts, United States of America

Job Description

We are searching for the best talent for a Senior Quality Engineer located in Raynham, MA
. The candidate will provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Conduct audits to good manufacturing practices, International Organization for Standardization and any other applicable standards.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, DePuy Synthes. After the separation, the role will be governed by DePuy Synthes employment processes and policies.

Duties and Responsibilities Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze 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.
• Supports the development of quality engineering and quality compliance for new product introductions and product life cycle management.
• Formulates and executes quality improvements.

Compliance/Regulatory

• Review/analyze whether current product and processes are in compliance with standards such as QSRs, ISO 13485, etc.
• Champions compliance to applicable global regulations and standards (e.g. QSRs, ISO, EN, MDD) including supporting internal and external audits.
• Conduct periodic line audits to assess production controls such as lot segregation and review audit results for corrective and preventive actions.

New Product/Process Introduction

• Partner with R&D and cross‑functional partners to ensure proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
• Support new product introduction as part of design transfer.
• Support Material Review Board activities.
• Investigate, document, review and approve non‑conformances, CAPAs and customer complaints;
  Escalate quality issues as appropriate.
• Own material identification, segregation, classification of defect types.
• Analyze and review effectiveness of preventive and corrective actions; review root‑cause investigations per established process.
• Own quality metrics including maintenance and review of leading/lagging indicators of quality.
• Represent as a subject‑matter expert (SME).

Product/Process Qualification

• Support or lead development of validation strategies.
• Approve IQ, OQ, PQ, TMV or software validation.

Production/Process Controls (Control Plans)

• Analyze and review effectiveness of preventive and corrective actions.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with process/product risk.
• Collect data and perform analytical/statistical analysis for process improvements.
• Develop, interpret and implement sampling plans.
• Assess effectiveness of measurement tools, destructive tests, non‑destructive tests, and measurement system analysis.
• Assess and interpret common vs. special cause variation in manufacturing processes.

Risk Mitigation

• Document, justify, review or analyze potential risk changes beyond current controls.
• Assess need for risk mitigation techniques; determine effectiveness of implemented improvements.

Strategic

• Analyze and review preventive and corrective actions; review root‑cause investigations.

Qualifications / Requirements

• University/bachelor’s degree or equivalent.
• 4 to 6 years of relevant work…