Principal Design Quality Specialist

Compass Consulting Group in Pleasanton, CA

  • Industry: Scientific Research - Chemistry/Material Science
  • Type: Full Time
  • Compensation: $71,953.33 - 147,180.00 / Year*

Job Description for Principal Design Quality Specialist

  • Provide Design Control guidance to product development teams under direction from Life Cycle Teams and be the single point representative for all Quality Management activities for Project Teams. May serve as Quality Functional Lead and/or proxy for Life Cycle Teams, as necessary.

  • Review and approve documentation consistent with design control regulations and guidance s and SOPs. Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, non-clinical protocols and reports, design transfer documents, labeling, clinical plan and reports, risk management plans and reports, project plans and milestone documentation.

  • Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy. May engage and lead difficult discussions, challenge the status quo, identify mutually beneficial compromises with cross functional colleagues at the Project Team level. Work closely and partner with DQA colleagues within and across sites with a goal of DQA alignment.

  • Author Quality Reports. Advise and support Project Teams during the planning of milestones. Assist management in assessment of whether the project has met requirements to pass milestone.

  • Lead or support development or continuous improvement of design control-related procedures to ensure effective, efficient and compliant processes. May serve as the primary Quality point of contact for process improvements and SOP revisions working closely with the respective SOP owner and DQA leadership.

  • Supports QMS compliance-related activities including but not limited to, internal and external audits/inspections, non-conformance management, qualification/validation activities.

Job Related Experience

At least 8 years experience under established quality regulations, advanced level knowledge of in-vitro diagnostic products and processes or demonstrated leadership in a specific focus area; design quality, clinical quality, vigilance, safety, research and development. Strong track record of successful collaboration on compliant solutions with cross-functional technical/project teams. Evidence of subject matter expertise and leadership in one or more process or focus area. May have people management experience.

Education and Experience

Bachelor s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline, or equivalent combination of education and work-related experience.

* Estimated salary

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