Quality Engineer - Medical Devices - Akkodis : Job Details

Akkodis is Seeking a Quality Engineer as a contractor for the location of Arden Hills MN. It is a contract Position for 12 months. Ideally looking for a candidate with experience in Medical device.

Pay Range: $30 - $37/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Duties

• Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.

• Performing complaint investigations in accordance with local and global processes.

• Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of document releases.

• Responding to Competent Authority Requests.

• Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through the sales organization.

• Providing input for process improvement and helping develop tactical approaches to implement team strategies

• Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.

• May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project teams comprised of functional experts and local managers.

• Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves.

• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Minimum requirements:

• BS with 1-3 years of relevant experience.

• A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems.

• Understanding and a command of highly technical engineering topics and applied statistics.

• Ability to independently manage project work to define and consistently meet delivery dates.

• Understanding and experience operating within quality system processes and procedures.

• Strengths in communication (verbal and written) and data analysis skills.

Preferred Qualifications

• Engineering Degree with 2+ years of relevant medical device experience.

• Strong technical understanding of medical device therapy products.

• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.

• Strong Technical Writing skills.

• Experience with the quality system escalations, CAPA investigations and field assessments.

• Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis.

• Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.

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 610 ### #### or [email protected].

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