Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Ensuring product and process excellence for life-changing therapies with an accent on quality standards, compliance, and reliability. Focus on designing inspection mechanisms, performing statistical analysis, and implementing corrective measures in a manufacturing environment.

Location: Onsite in Plymouth, Minnesota, USA. Must possess unrestricted U.S. work authorization.

Salary: $66,400 - $99,600

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Develop and maintain quality standards and protocols for material processing.
• Collaborate with engineering and manufacturing functions to ensure quality standards are implemented.
• Devise and implement methods for inspecting, testing, and evaluating product and equipment precision.
• Design inspection and testing mechanisms and conduct quality assurance tests.
• Perform statistical analysis to assess cost and responsibility for non-conforming materials.
• Ensure corrective measures meet reliability standards and maintain compliant documentation.

Requirements

• Bachelor’s Degree in Engineering, Science, or a technical field.
• Unrestricted U.S. work authorization is required at the time of hire (sponsorship not offered for this level).
• Ability to work onsite 5 days a week at the Nathan Lane Manufacturing site in Plymouth, MN.

Nice to have

• Experience reviewing technical documentation.
• Knowledge of process validation (IQ, OQ, PQ) and Test Method Validations.
• Familiarity with Risk Management documentation, including DFMEA and PFMEA.
• CAPA knowledge and experience with problem-solving tools.
• Previous experience supporting a manufacturing line.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and a global well-being program (Simple Steps).
• Employee Stock Purchase Plan and tuition assistance/reimbursement.
• Life insurance and long-term disability leave.