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Design Quality Engineer 2

San Diego, CA 92101

Posted: 03/22/2023 Employment Type: Contract Job Category: Engineering Job Number: 548968 Is job remote?: Yes Country: United States

Job Description


In this Design Quality Engineer 2 - Risk Management role, you will be a quality engineer reporting into Client's Development Quality organization. You will be responsible for performing risk management activities associated with Client's on-market in-vitro diagnostic (IVD) products ranging from Whole Genome Sequencing Platforms, Assays, Automation, and Software products in adherence to Client's Quality Management System processes. This role will collaborate deeply with product SMEs in product development, manufacturing, as well as with Design Quality Engineering functions at Client.

This role requires an intimate understanding of the following:
  • Product Risk Management in accordance with ISO 14971:2019
  • A highly disciplined approach to creating and maintaining risk documentation
  • The ability to quickly grasp highly technical concepts associated with Client's Next Generation Sequencing product portfolio.

This role will report into Client's Development Quality organization.

Responsibilities:
  • Execute remediation of assigned IVD Risk Documentation in accordance to Client's Risk Management process into Client's electronic

Product Risk Management System.
  • Collaborate with area-specific SMEs in Design, Process, Usability, and Software as required to review and approve updated risk documentation.
  • Provide management with status updates on assigned responsibilities- escalating issues and proposing solutions as necessary.

Requirements:
  • Bachelor's degree or higher in Engineering, Chemistry, Biochemistry or related disciplines.
  • 3+ years in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic or Medical Device development and/or manufacturing preferred.
  • Demonstrated experience in executing and managing the complexities of system and sub-system level risk management activities like Hazard Analysis and Failure Modes and Effect Analysis (FMEA) in accordance with ISO 14971.
  • Exceptional computer skills (specifically tool navigation, data entry, and collaboration) using web-based applications like SAP, Siemens Teamcenter, Confluence, Microsoft Office/Teams, etc.
  • Demonstrated ability to accomplish goals while working across departments.
  • Highly effective communication, facilitation, coaching, and negotiation skills.
  • Adaptable to fast-paced, dynamic work environment with shifting demands.
38-43 pay rate range
**salary will be commensurate with experience**
CO, NY candidates may not be considered

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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