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Development Quality Engineer

Company: GForce Life Sciences
Location: Saint Paul
Posted on: November 18, 2021

Job Description:

Job Title: Development Quality Engineer IIDuration : 8+ Month Location: St Paul, Minnesota (Onsite)

  • Candidates with a med device background preferred but not required however an enthusiastic interest in the med-devices would be a plus.
  • 90% of work entails maintaining documentation and adhering to updated standards such as biocompatibility, corrosion, sterilization, etc., and is not specifically hands-on work.
  • Some EU MDR remediation but work will primarily focus on paper/computer trails and tracking.
  • Ideal candidates will be highly organized, comfortable with desk work, tracking, and standardization protocols.
  • Ideal candidates would have a degree focused more on biomedical and recent grads will be reviewed.
  • Prefer some internship or co-op experience.
  • Possible extension and or conversion to FTE for right individuals

    Education: Bachelor level degree in an Engineering Discipline or other technical field experience
    Duties: Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects, accountable for generation of PDP design verification test plans/reports for product/system requirements, lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports,-- Lead and/or support on-time completion of Design Control deliverables-- Support the establishment of objective, measurable, and verifiable product requirements-- Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities-- Lead Risk Management activities from product concept through commercialization-- Support test method development and lead test method validation activities-- Support manufacturing process development & qualification for new product and design changes-- Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications-- Support biocompatibility and sterilization qualifications-- Support audits and quality system improvement activities-- Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.-- Comply with client, U.S. FDA, EUMDR and other requirements, as applicable.-- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers. Basic
    Qualifications:--- Bachelor's degree in Engineering or Technical Field.--- Minimum of 1 year of experience or Internship exp in R&D, Process/Manufacturing Engineering, and/or Quality with at least 0-1 year supporting product development.--- Experience in medical devices and associated regulations/standards.--- Experience in test method development and validation--- Experience in preparing risk assessments, FMEA and other risk documents. Preferred Qualifications:--- Advanced Degree in Engineering/Technical Field--- Experience in active implantable medical devices.

Keywords: GForce Life Sciences, St. Paul , Development Quality Engineer, Engineering , Saint Paul, Minnesota

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