Akkodis is Seeking a System Validation Engineer as a contractor for the location of Maple Grove MN. It is a contract Position for 6 months. Ideally Looking for a candidate with experience in Medical Device Manufacturing Industry.
Pay Range: $50 - $58/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
Duties
- Working within a team of Software Engineers that support embedded R&D systems in the Peripheral Interventions division.
- Actively contributing to all aspects of Software Quality Assurance activities in an FDA-regulated medical device environment and ensuring that software verification and validation is carried out in compliance with site/corporate policies and procedures.
- Performing independent reviews of design, development, and testing of software/firmware used Peripheral Interventions product lines throughout their entire System Development Life Cycle.
- Reviewing and approving documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix, and qualification reports along with support documentation for equipment qualification.
- Reviewing and approving changes to existing systems from a Software QA perspective, ensuring changes are implemented in compliance with internal procedures and external standards.
- Reviewing test results for GDP compliance and ensuring that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.
- Ensuring that best software QA practices are employed by all departments so that software/firmware-based systems are developed, qualified, and maintained in a manner that provides assurance the system conforms to both internal and external requirements.
- Supporting site audits, non-conforming events, and CAPAs as required.
- Establish and promote a work environment that supports the Quality Policy and Quality System.
- Establish and cultivate internal business relationships to facilitate task completion and actively participate in project teams.
Required Qualifications:
- Bachelor's level degree or higher in Science/Engineering/Software discipline.
- Minimum of 2 years of related work experience in Software QA and/or computer systems validation.
- Knowledge of the System Development Life Cycle (SDLC), preferably with automated manufacturing and computerized lab systems.
Preferred Qualifications:
- Understanding of 21 CFR Part 11 (electronic records/electronic signature).
- Experience supporting manufacturing in regulated industry.
- Ability to understand and evaluate procedural documents to ensure compliance with all applicable regulations and requirements.
- Strong organizational skills with the ability to multitask and prioritize competing responsibilities in a fast-paced environment.
- Customer service-oriented with the ability to communicate effectively (written and verbally) with individuals at all levels.
- Ability to work independently and collaborate with internal teams.
- Strong problem-solving and critical thinking skills; analytical, process, and results oriented.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at .
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance