Supplier Quality Engineer

Job content

• Provide overall quality assurance leadership in the management of suppliers engaged in the production of Johnson and Johnson medical device products
• Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
• Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO)
• Understand supplier performance metrics and what they mean to the business
• Promote continuous improvement and Process Excellence activities within the Global Supply Chain
• Change control management and qualification of supplier process changes and supplier transfers programs
  

• A minimum of a Bachelor’s degree is required, preferably in an Engineering, Life Science, or related discipline
• A minimum of 6 years of experience in a highly regulated industry is required
• Experience in the Medical Device industry and/or Pharmaceutical industry is required
• Validation experience within the Medical Device industry
• FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required
• Experience in root cause analysis is required
• Six Sigma, Lean, or ASQ Certification and training an asset
• This position may require some EU based travel
• Very good communication skills in English (spoken and written) are mandatory. German is a nice to have