Duration
- 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.
Responsibilities
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)
