Senior QA Engineer, Medical Devices — Lifecycle Quality

Nextern, Inc.; Maple Grove (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental & Vision)

Retirement Plan with Company Match

Paid Time Off

Personal Days

Birthday Holiday

Lifetime Membership Subsidy

Wellness Resources

Life Insurance (Basic, Voluntary & AD&D)

MN Paid Leave

Short-Term & Long-Term Disability

Taco Thursdays!!!

Job summary

Nextern, Inc. is looking for a Quality Assurance Engineer in Maple Grove, Minnesota. This role involves ensuring operational quality for manufacturing programs and supporting development activities. Candidates should have a Bachelor's degree in a life science discipline and at least 5 years of relevant experience, with strong skills in quality systems and methodologies. The position offers benefits including health care plans, retirement with company match, and unique perks like 'Taco Thursdays'.

Qualifications

• 5+ years in medical device development or 3+ years in Design Assurance/Quality Engineering.
• Experience with quality systems in 21 CFR 820 and ISO 13485.
• Knowledge of ISO 14971 and risk management in product development.

Responsibilities

• Support development activities for commercial manufacturing readiness.
• Compile quality metrics and drive corrective actions.
• Oversee incoming inspection and supplier quality issues.

Skills

Quality tools and methodologies

Creative thinking

Communication skills

Attention to detail

Education

Bachelor's Degree in life science or equivalent

Tools

Minitab

MS Office Suite

PLM software (Windchill, Agile, Propel)

Job description

Nextern, Inc. is looking for a Quality Assurance Engineer in Maple Grove, Minnesota. This role involves ensuring operational quality for manufacturing programs and supporting development activities. Candidates should have a Bachelor's degree in a life science discipline and at least 5 years of relevant experience, with strong skills in quality systems and methodologies. The position offers benefits including health care plans, retirement with company match, and unique perks like 'Taco Thursdays'.