Senior Quality Control Engineer

Akkodis is Seeking a Senior Quality Control Engineer for location of Maple Grove MN/ Hybrid.

This is a 12-month contract Position. Ideally looking for a candidate with experience in medical device Manufacturing Industry.

Pay Range: $60 - $75/hour;
The rate may be negotiable based on experience, education, geographic location, and other factors.

We have an exciting opportunity for a Principal Design Quality Engineer supporting development projects within Cardiology division. This position supports a major product category with high visibility. This person will utilize their established understanding of design controls to contribute to a cross functional team tasked to evaluate the health of existing product design history files and triage the need for remediation.

• In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams.
• Provide expertise to assess adequacy of test method validation coverage, documentation and execution.
• Independently and cross functionally assess acceptability of design requirements and risk controls as demonstrated in the design history file documentation. Expectations included demonstrated acumen of user needs, hazard analyses, and design verification deliverables.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

• Bachelors degree in mechanical engineering, Biomedical Engineering or related Engineering field of study.
• Minimum of 8 years of experience in design assurance, quality, or related medical device or regulated industry experience.
• Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation.
• ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use.
• Excellent organizational and planning skills; drives for results.
• Strong communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.

• Experience in developing test methods. Problem solver, capable of facilitating the problem‑solving process.
• Adaptable and effective collaborator in a team environment and in self‑directed work.
• Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.
• Experience with Class III Medical Devices.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Ayush Kumar at  or

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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