Quality Engineer

Advantage Technical; Maple Grove (MN); On-site; USD 45,000 - 76,000; Full time

Benefits offered by this job

Medical, dental, vision, and pet保险

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

People Perks Program

Health Savings Account (HSA)

AD&D Insurance

Job summary

Advantage Technical in Maple Grove, MN is seeking an experienced Quality Engineer for our medical device team. The role focuses on CAPA, post-market surveillance, quality operations and continuous improvement to support life-changing healthcare products.

Responsibilities include maintaining quality systems, conducting root cause analysis, coordinating CAPA investigations, and collaborating with manufacturing, operations, design, and suppliers to ensure regulatory compliance and ongoing product

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years medical device quality engineering experience preferred.
• Experience with post-market surveillance activities.
• Experience owning and managing CAPA processes.
• Strong root cause analysis and problem-solving skills.
• Ability to work independently and manage multiple priorities.
• Experience supporting quality systems and regulatory compliance.

Responsibilities

• Support quality systems and quality operations activities.
• Author and maintain post-market surveillance reports.
• Coordinate and manage CAPA investigations and corrective actions.
• Conduct root cause analysis and drive resolution of quality issues.
• Support design change activities and quality documentation reviews.
• Collaborate with manufacturing, quality, operations, and design teams.
• Communicate with contract manufacturers regarding quality requirements.
• Review and maintain supplier corrective action records.
• Ensure compliance with regulatory, customer, and quality system requirements.
• Identify opportunities for process improvement and quality enhancements.

Skills

CAPA management

Root cause analysis

Quality systems knowledge

Regulatory compliance

Independent work

Education

Bachelor's degree in Engineering or related field

Job description

Now Hiring: Quality Engineer

Location: Maple Grove, MN

Pay Rate: $55.00/hr

Are you an experienced Quality Engineer with a background in medical devices? Join a leading medical device team supporting critical quality systems, post-market surveillance activities, and continuous improvement initiatives. This is an excellent opportunity to apply your expertise in CAPA, root cause analysis, and quality operations while making an impact on life-changing healthcare products.

Job Duties

• Support quality systems and quality operations activities
• Author and maintain post-market surveillance reports
• Coordinate and manage CAPA investigations and corrective actions
• Conduct root cause analysis and drive resolution of quality issues
• Support design change activities and quality documentation reviews
• Collaborate with manufacturing, quality, operations, and design teams
• Communicate with contract manufacturers regarding quality requirements
• Review and maintain supplier corrective action records
• Ensure compliance with regulatory, customer, and quality system requirements
• Identify opportunities for process improvement and quality enhancements

Experience Requirements

• Bachelor's degree in Engineering or related field
• 5+ years of medical device quality engineering experience preferred
• Experience with post-market surveillance activities
• Experience owning and managing CAPA processes
• Strong root cause analysis and problem-solving skills
• Ability to work independently and manage multiple priorities
• Experience supporting quality systems and regulatory compliance

Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks Program
• Health Savings Account (HSA)
• AD&D Insurance

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

About Us

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.