Quality Engineer at Akkodis Quality Engineer at Akkodis in Minneapolis, Minnesota Posted in 4 days ago.

Type:

full-time Akkodis is seeking a Quality Engineer IV role is 6 months contract with a client located in Arden Hills, MN .

Pay Range:

$70-$80/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Key Responsibilities:

• Leads or supports projects focused on developing, maintaining, and improving product complaint monitoring strategies and criteria.
• Evaluates complaint data, product risk profiles, lifecycle characteristics, and usage patterns to determine appropriate monitoring methods and thresholds.
• Develops, documents, and defends the rationale for product-specific trending criteria using statistical principles and engineering judgment.
• Partners with cross-functional stakeholders including Product Development, Manufacturing, Clinical, Regulatory, Quality, and Complaint Investigation teams to ensure monitoring approaches remain appropriate and effective.
• Reviews and periodically reassesses existing monitoring strategies to ensure they remain aligned with product performance, risk, and regulatory requirements.
• Performs complaint trending analyses and investigates potential signals, anomalies, or emerging product performance concerns when identified.
• Documents technical justifications, monitoring decisions, peer reviews, and supporting evidence in accordance with quality system requirements.
• Supports implementation and continuous improvement of complaint monitoring processes, work instructions, and best practices.
• Uses Excel and other available tools to evaluate complaint and product performance data, generate supporting analyses, and maintain documentation.
• Participates in audits, inspections, and quality system activities related to complaint monitoring and post-market surveillance processes.
• Acts as a technical resource for complaint trending methodologies, monitoring criteria development, and post-market performance evaluation.
• May mentor less experienced employees and lead cross-functional initiatives related to complaint monitoring and signal detection.

Quality System Requirements In all actions, 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.

Job Requirements:

Required Qualifications

• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related technical field.
• 7+ years of experience in medical device quality, post-market surveillance, complaint handling, complaint trending, reliability engineering, product performance monitoring, or a related field.
• Working knowledge of statistical concepts and their practical application to quality and product performance monitoring.
• Experience developing, evaluating, or maintaining complaint trending, monitoring, or signal detection methodologies.
• Strong Microsoft Excel skills, including data manipulation, trend evaluation, and reporting.
• Demonstrated ability to apply technical judgment and risk-based thinking to solve complex problems.
• Strong written and verbal communication skills with the ability to document and explain technical rationale to diverse audiences. Preferred Qualifications
• Experience within the medical device industry.
• Experience with complaint handling, post-market surveillance, or product performance monitoring programs.
• Knowledge of FDA post-market surveillance expectations, EU MDR PMS activities, or related quality system requirements.
• Experience participating in cross-functional reviews involving Quality, Regulatory Affairs, Clinical, Manufacturing, or Product Development.
• Experience developing technical reports, justifications, engineering assessments, or quality documentation.
• Familiarity with statistical process control, control charts, trend detection methodologies, or quality engineering techniques. Desired Skills
• Statistical reasoning and application of basic-to-intermediate statistical methods
• Product complaint trending and signal detection
• Technical writing and rationale documentation
• Cross-functional collaboration and stakeholder engagement
• Problem solving and critical thinking
• Project management and organization
• Advanced Microsoft Excel If you feel this is not something that you are currently interested in, but know of someone, that might be, please share the details with them or let me know their details so I can reach out to them!

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. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy. 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