Quality Engineer

Dynamic Group IncRamsey, MN
7h$75,000 - $100,000

About The Position

The Quality Engineer (QE) provides quality engineering support to medical molding manufacturing and product realization processes to ensure quality, compliance, and productivity expectations are met. This role supports both New Product Introduction (NPI) and existing production through validation, data analysis, metrology, and cross-functional collaboration with Engineering, Operations, and Quality. The QE role is a technical and analytical position that blends hands-on engineering support with documentation, reporting, and continuous improvement activities.

Requirements

  • Bachelor’s Degree in Quality, Mechanical, Industrial, or another Engineering discipline.
  • Minimum of 3 years of experience in an engineering or quality role within a manufacturing or machining environment.
  • Working knowledge of inspection equipment including CMM, VMM, calipers, micrometers, gauges, drop indicators, and other quality tools.
  • Experience applying statistics and data analysis methods such as control charts, sampling plans, Gage R&R, and DOE.
  • Strong problem-solving and analytical skills.
  • Solid understanding of process capability and validation principles.
  • Proficient understanding of GD&T.
  • Effective written and verbal communication skills.
  • Strong documentation and technical writing abilities.
  • Proficient use of Microsoft Office (Outlook, Word, Excel).
  • Ability to work independently while collaborating effectively in cross-functional teams.
  • Strong organizational skills with the ability to multitask and prioritize.
  • High attention to detail.
  • Working knowledge of ERP systems.

Nice To Haves

  • Quality engineering experience in a plastic injection molding manufacturing environment.
  • Medical device industry experience including ISO 13485 and FDA CFR Part 820.
  • Advanced metrology experience, including CMM programming (Zeiss preferred).
  • Strong background in data-driven problem solving and technical analysis.
  • Minitab or similar statistical software experience.

Responsibilities

  • Serve as a quality interface for Engineering and Production related to customer requirements, validations, and quality concerns.
  • Provide quality engineering support for both new and existing products, tools, and processes.
  • Collaborate with Engineering on process development, refinement, and ongoing validation activities.
  • Support manufacturing with problem-solving, root cause analysis, and corrective and preventive actions (CAPA).
  • Lead and support validation activities for processes, equipment, and metrology systems (IQ, OQ, PQ).
  • Develop validation protocols, plans, and reports.
  • Analyze and interpret validation and process data to ensure compliance and capability.
  • Oversee and support software validation activities as required.
  • Ensure adherence to ISO 13485 and applicable FDA regulatory requirements.
  • Perform statistical analysis, trending, and reporting of quality and process data.
  • Support and develop measurement strategies, inspection plans, and best measurement practices.
  • Utilize inspection and metrology equipment including CMM, VMM, and other quality tools.
  • Support CMM programming and advanced metrology analysis (Zeiss experience preferred).
  • Use data-driven methods to identify waste, variation, and opportunities for improvement.
  • Participate in internal process improvement initiatives.
  • Support cross-functional teams including Engineering, Operations, and Quality to ensure robust and repeatable processes.
  • Assist with print and inspection interpretation and ensure customer requirements are clearly understood and met.
  • Maintain strong documentation practices and compliance with internal and external standards.
  • Travel as required to support customer and supplier needs.
  • Continuously seek opportunities to improve quality systems, processes, and the customer experience.

Benefits

  • Dynamic Group offers a comprehensive benefits package designed to support employees' health, financial security, and overall well-being.
  • Medical insurance is provided through an Individual Coverage Health Reimbursement Arrangement (ICHRA), with tax-free contributions based on age and coverage level, beginning the 1st of the month after 30 days of service.
  • Dental and vision insurance plans are also available with affordable monthly premiums.
  • Retirement savings are supported through a 401(k) plan with auto-enrollment at 4% after 90 days, a company match, and full vesting after 4 years.
  • Additionally, the company provides life insurance, short-term and long-term disability coverage, and access to an Employee Assistance Program (EAP) at no cost.
  • Employees can also choose optional benefits, including supplemental life insurance and legal/ID protection plans.
  • This benefits package ensures employees have the resources they need for health, security and peace of mind.
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