Dynamic Group · 14 hours ago
Quality Engineer
Ramsey, MN
Full-time
Onsite
Mid Level
$75K/yr - $100K/yr
3+ years expDynamic Group is a leader in precision manufacturing and custom injection molding for the medical device industry. The Quality Engineer provides quality engineering support to ensure compliance and productivity expectations are met, focusing on new product introduction and existing production through validation and data analysis.
CommercialManufacturingPlastics and Rubber Manufacturing
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
Qualification
Required
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
Preferred
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
Company
Dynamic Group
Dynamic Group, Inc. (DGI) is a leading contract manufacturer specializing in precision injection-molded plastic components and high-precision molds.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Joe McGillivray
CEO
Owoseni Emmanuel
CEO of St. Dynamic International school Abuja
Company data provided by crunchbase