• Michael Page
  • $94,360.00 -141,170.00/year*
  • Southborough , MA
  • Engineering
  • Full-Time

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Job Description

  • CAPA - Conduct failure investigations, root-cause analysis, and corrective action implementation. Provides leadership and technical expertise for effective Root Cause Analysis
  • ISO 13485, ISO9001
  • Develop and implement quality improvement with working knowledge of Quality standards and systems.
  • Support Manufacturing Lean initiatives & be a hands-on engineer.
  • Ability to be hands-on quality advocate for the brand
  • Work cross functionally with other in-house departments & contract manufacturers
  • Supplier / Customer Interface- there will be 20% travel for the first 2-3 months, but will slow down significantly afterwards to about once a month.

The Successful Applicant

  • Minimum 6 years related experience in a regulated environment
  • B. S in Engineering, or other scientific degree
  • Background in Medical Device or Pharmaceutical Industry
  • Strong oral and written communication skills
  • Complete understanding of Quality Systems
  • Experience with Contract Manufacturers
  • Experience in Process validation, statistical data analysis, plastic injection molding, drafting/reviewing protocols and reports, inspection techniques, etc.

What's on Offer

  • Competitive Compensation
  • Team Oriented Work Environment
  • Structured Growth Plan
  • Bonus opportunity
  • Stock Options
  • Strong benefits package - medical dental vision etc.

Associated topics: bio, biology, biomedical, bioprocess, bioprocessing, metabolic, nutrition, pain, parenteral, therapeutic

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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