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System One Quality Engineer in Burlington, Massachusetts

Quality Engineer

Degree:

  • BS degree in chemistry, physics, chemical engineering, biomedical or mechanical engineering

    Experience:

  • 2-5+ yrs. experience in the Med Device or Pharma industry in a similar role

    "MUST HAVES":

  • Mechanical aptitude and/or biologic mindset(Microbiology or chemistry background)

  • Computer savvy; excel data manipulation

  • Root Cause Analysis tools (5-why/fishbone etc.)

  • Exp. with Quality Systems

  • Exp. with CAPA

  • Exp. with Complaints

  • Exp. with Non-Conformities

  • Design control exp. is a plus

    Primary Duties/Responsibilities:

  • Will be focused on CAPAs, Complaints, and audit remediation

  • Develops and initiates standards and methods for inspection, testing, and evaluation.

  • Approximately 15% of the day will be spent gowned and working in a cleanroom

  • Plans and/or conducts the analysis, inspection, design, test, and/or integration to assure the quality of the assigned product or component

  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data

  • Identifies, analyzes, and implements improvements to both manufacturing and design processes and products

  • Performs quality engineering reviews of supplier quality information in order to qualify both the vendor, as well as, vendor supplied product and/or services

  • Prepares reports to communicate involvement and results of quality activities. (Complaints, CAPAs, NCMRs)

    Location: Burlington, MA area

    Start Date: ASAP!!

    Duration: Direct Hire

    Hours: Mon-Fri; 8am-4:30pm

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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