Onsite: Quality Systems Engineer – 2 Spots (234948)

Life Sciences & Technology


  • 6 plus months

Job Description

  • Client submitting IDE at the end of the year, joining a team of 5. Client is looking for a Quality Systems Engineer.


Design Verification Support:

  • Assist in design verification review and report reviews.
  • Support the design verification phase of projects.
  • Ensure compliance with design verification protocols and procedures.

Quality Systems Support:

  • Support all quality needs within the team.
  • Ensure compliance with Good Distribution Practice (GDP) regulations.
  • Capture data during test runs and ensure test runs are compliant with regulatory requirements.

Risk Management:

  • Conduct UFMEA (Use Failure Mode and Effects Analysis) and review risk management analysis.
  • Implement a Human Factors affirmative approach in the design and verification processes.
  • Cleanup UFMA (Use Failure Mode and Analysis) and review user manuals, protocols, and reports.

Short-Term Assignments:

  • Conduct laptop installation reviews.
  • Collaborate with non-product software teams for Installation Qualification (IQ).

Process Improvement:

  • Assist in executing process improvement initiatives.
  • Work with the equipment manager on process optimization.

Skills Required

  • Proficiency in Design Verification processes.
  • Strong understanding of Risk Management principles.
  • Experience with non-product software and System Configuration Management(plus)
  • Ability to collaborate effectively within a multidisciplinary team.
  • Excellent communication and documentation skills.
  • Attention to detail and ability to ensure compliance with regulatory requirements.


Onsite: Quality Systems Engineer – 2 Spots (234948)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
US On-Site

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