Senior Quality Engineer

Nextern is a medical device manufacturing company specializing in integrated systems and therapy delivery solutions.
Maple Grove, MN, USA
$80,000 - $100,000
Quality
Senior Software Engineer
In-Person
2+ years of experience
Healthcare

Description For Senior Quality Engineer

Nextern is seeking a Senior Quality Engineer to manage quality relationships with key customers in the Integrated Systems and Therapy Delivery businesses. This role is crucial for maintaining high-quality standards in engineering, manufacturing, and supply chain operations. The position involves overseeing critical processes such as CAPA, SCAR, process qualification, and validation, while providing technical leadership in issue resolution and root cause analysis. The ideal candidate will have extensive experience in medical device processes, including hydrophilic coating, injection molding, and various state-of-the-art technologies. This role offers an opportunity to work with international teams in China and Vietnam, mentor junior staff, and contribute to maintaining excellence in medical device manufacturing. The position comes with comprehensive benefits and a competitive salary range of $80,000-$100,000 annually. Located in Maple Grove, Minnesota, this role is perfect for quality professionals seeking to make a significant impact in medical device manufacturing.

Last updated a day ago

Responsibilities For Senior Quality Engineer

  • Manage quality relationship between Nextern and key customers
  • Oversee CAPA, SCAR, process qualification and validation
  • Lead technical issue resolution and root cause analysis
  • Oversee various systems, applications, and tools including database analysis
  • Collaborate with supply chain resources in China and Vietnam
  • Mentor junior engineering staff

Requirements For Senior Quality Engineer

  • Master's degree in engineering management or related field
  • Risk Management process execution experience
  • Process Validation and control of specialty medical device processes
  • Test Method identification and validation of automated inspection technologies
  • Failure Analysis of Returned Goods experience
  • Data analysis using statistical techniques in Minitab and Microsoft Excel
  • Experience with Oracle Agile and Epicor software systems

Benefits For Senior Quality Engineer

Medical Insurance
Dental Insurance
Vision Insurance
401k
Parental Leave
  • Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan with Company Match
  • Paid Time Off, Personal Days, and Birthday Holiday
  • Lifetime Membership Subsidy and Wellness Resources
  • Life Insurance (Basic, Voluntary & AD&D)
  • Family Leave (Maternity, Paternity)
  • Short-Term & Long-Term Disability
  • Taco Thursdays

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