Quality Assurance Engineer Senior

Our clients contribution is to inspire innovative solutions that advance scientific discovery. Their goal is to provide solutions for improving healthcare around the globe. They are part of a team of life science companies who are developing products that are paving the way in the fight to save lives.

If you are looking for an opportunity to contribute your skills and knowledge our client is looking for a Quality Assurance Engineer (Senior).

• Fulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle
• Collaborate with cross functional teams to ensure that the product Design History File (DHF) is auditable traceable concisely organized complete and supports regulatory product registration needs
• Ensure compliance with applicable regulatory agency requirements published standards company policies/procedures local procedures/work instructions and project specific plans
• Work cross functionally on defining performance requirements conducting risk analysis reviewing verification and validation test plans execution and data to complete the design transfers.

Salary: $DOE/ hr (contract)

Schedule: MF 8am 5pm Hybrid TuesWedThurs onsite

Location: West Sacramento CA

QUALIFICATIONS

• BS degree in Engineering Technology or Science from an accredited college/university w/ 5 years relevant working experience
• OR Masters degree in field w/ 3 years relevant working experience
• OR Doctoral degree in field w/ 02 years relevant working experience
• Agile Development experience
• Previous experience in Design Assurance (QA) supporting software/hardware development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance)
• Previous experience in medical device or other regulated industries
• Effective leadership and interpersonal skills
• Good written and verbal communication skills
• Must be authorized to work in the US for any employer
• The position is subject to passing a background check and drug screen

Keywords: quality assurance QA quality systems design control DHF quality control medical device quality production FDA ISO regulated environment manufacturing immunoassay US and international regulations Agile development engineering life science

By applying to this position you are confirming that you understand the requirements needed for this position and further confirm that you possess the necessary skills and requirements as outlined above.