Senior Quality Engineer, Depuy Synthes

Johnson & Johnson Johnson & Johnson · Pharma · Palm Beach Gardens, FL +1

Senior Quality Engineer at Johnson & Johnson's DePuy Synthes division in Palm Beach Gardens, FL. This role focuses on quality assurance leadership for on-site manufacturing, ensuring compliance with GMP, ISO, and other standards. Responsibilities include supporting New Product Introduction and Value Improvement projects, managing product/process complaints, overseeing audits, and ensuring comprehensive measurement systems for quality and reliability. Requires a Bachelor's degree and 2-4 years of experience in regulated industries, with in-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA, ISO) and process quality/validation.

What you'd actually do

  1. Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
  2. Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
  3. Addresses and corrects product and process complaints.
  4. Reports on contract manufacturer performance metrics and ensures management reviews.
  5. Oversees audits of all quality system categories to assess compliance to process excellence standards.

Skills

Required

  • Bachelor's degree
  • 2-4 years of related work experience
  • Experience working in regulated industries
  • Professional quality or Manufacturing Engineering experience
  • In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)
  • Experience and a proven track record of implementing appropriate risk mitigation
  • Strong communication, teamwork, problem solving and decision-making skills
  • Experience in process quality and validation

Nice to have

  • Understanding of the NPI (New Product Introduction) process
  • Analytical Reasoning
  • Coaching
  • Customer Centricity
  • Data Savvy
  • Document Management
  • Financial Competence
  • Good Automated Manufacturing Practice (GAMP)
  • Lean Supply Chain Management
  • Process Improvements
  • Quality Control (QC)
  • Quality Services
  • Quality Standards
  • Quality Systems Documentation
  • Quality Validation
  • Scie

What the JD emphasized

  • regulated industries
  • product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)
  • process quality and validation