Senior Design Assurance Scientist

1970-01-01Davis Companies Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Senior Design Assurance Scientist

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The Davis Companies is partnering with a large Laboratory equipment manufacturer in Chaska, MN to find a Senior Quality Assurance Scientist .  This contract associate will be involved in creation and/or updates of design history file documentation needed to support IVDR (In vitro diagnostic regulations (EU 2017/746)). This position will report to the Director of Quality Assurance and will assist in compiling documentation for IVDR submissions.

Responsibilities of Senior Quality Assurance Scientist:

  • Create templates for reagent and/or system design history file documents, including population with applicable data and required content to conform to internal Quality System requirements and IVDR requirements.
  • Collaborate effectively with other functional IVDR team members in gathering required information for completion of the IVDR files.
  • Clearly and quickly communicate when potential gaps are found.
  • Work with minimal direction to complete assigned project deliverables, procedural updates, assessments, or data analysis task individually or delegate to quality function specialists within the organization.
  • Ensure that assigned tasks are compliant to Beckman applicable procedural requirements as well as to regulatory requirements. Review and update product safety risk assessments.
  • Ensure that risk management activities are performed in accordance with company procedure and ISO 14971; Review and approve Design History file documents in preparation for IVDR submissions.
  • Ensure the product Design History File (DHF) is auditable, traceable, complete, and supports regulatory product registration needs.

Qualifications of Senior Quality Assurance Scientist:

  • BS in Biochemistry, Immunology or related technical field with minimum of 5+ years of experience or Master’s degree in field with minimum of 3+ years of experience, or Doctoral degree with 0-2 years of experience.
  • 1-2 years of experience within Medical Device product design and/or manufacturing environment (IVD and Medical Device industry preferred)
  • Well-developed skills in writing, review documentation, and oral communication within a technical team. Practical experience in other Quality disciplines (Supplier, Manufacturing, Design, Post-market Surveillance, Quality Systems, and Quality Control) preferred
  • Fluent in English language. Proficient in word processing, spreadsheets, MS PowerPoint, and project management skills.
  • Knowledge and understanding of MDR/IVDR preferred


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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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