Quality Engineer

Advantage Technical is hiring a Quality Engineer in Arden Hills, MN. Join a collaborative team focused on improving patient outcomes through data-driven investigations and continuous product improvement.

Pay: $37.00/hour

Schedule: 8:00 AM - 4:30 PM (Hybrid - Tuesdays and Thursdays report to site)

Quality Engineer Summary

In this role, you will be responsible for investigating product complaints, analyzing product performance data, and collaborating with cross-functional teams to ensure patient safety and continuous product improvement. This position is focused on data analysis and quality system compliance rather than hands-on product testing.

You will work within a highly collaborative team environment, leveraging technical expertise, analytical skills, and regulatory knowledge to identify trends, escalate potential risks, and support global quality initiatives.

Key Responsibilities

• Conduct complaint investigations in compliance with local and global quality system procedures
• Review laboratory analyses, customer feedback, and historical data to ensure accurate complaint coding and reporting
• Perform post-market surveillance by analyzing product performance data, identifying patterns and trends, and escalating potential product performance issues
• Support regulatory reporting activities, including responses to Competent Authority requests
• Prepare and deliver formal presentations on product performance to leadership teams, design engineering, and regulatory stakeholders
• Collaborate with cross-functional teams to support CAPA investigations, risk management, and product performance reports
• Apply statistical methods and data analysis software to support product risk documentation and quality initiatives
• Contribute to process improvement projects, including quality system enhancements and performance trending strategies
• Assist in project planning, including timelines, deliverables, and cross-functional coordination
• Foster a safe, diverse, and inclusive work environment aligned with company values and objectives

Minimum Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field
• 1-3 years of relevant experience in quality engineering, medical device, or regulated manufacturing environment
• Strong knowledge of engineering principles, applied statistics, and data analysis tools
• Proven ability to manage projects independently and meet deadlines
• Experience working with quality system processes, documentation, and compliance requirements
• Excellent written and verbal communication skills

Preferred Qualifications

• Bachelor's degree in Engineering with 2+ years of medical device quality engineering experience
• Strong technical understanding of medical device therapy products and risk management practices
• Experience in Hazard Analysis, Risk Assessment, CAPA investigations, and complaint trending
• Solid understanding of FDA, ISO 13485, and international medical device regulatory requirements
• Experience collaborating with Design Assurance, Medical Safety, Supplier Quality, and Manufacturing teams
• Demonstrated technical writing skills for regulatory and quality documentation

Employee Benefits

Enjoy a comprehensive benefits package that includes medical, dental, vision, and pet insurance; a 401(k) retirement plan; health savings accounts (HSA); commuter and parking benefits; life and AD&D coverage; an employee assistance program (EAP); and access to exclusive discounts and perks.

Ready to apply your skills to support innovation in patient care? Click "Apply Now" to be considered for this opportunity!

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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