Manufacturing Quality Engineer
A Manufacturing Quality Engineer position in Boxborough MA courtesy of Modis.
Seeking a driven Manufacturing Quality Engineer. This role is high-impact, with significant visibility within the organization, and the opportunity to provide personal influence towards a growing area of In-Vitro Diagnostic Device manufacturing. The Manufacturing Quality Engineer supports production/project activities and quality objectives, provides guidance to the Engineering, Production, and Project Manager teams, and has influence extending from the Dover supply chain through to the end customer.
• 5+ years of experience working with Medical Device (IVD instrument) production under ISO 13485:2016 and FDA QSR compliant Quality Systems
• Demonstrated knowledge of manufacturing, engineering, and quality tools and techniques, including: IQ/OQ/PQ, Design for Manufacturability (DfM), GD&T, IQ/OQ/PQ, GR&R, cGMP.
• Experience working in a Lean Manufacturing environment.
Owning and executing the following:
• Manufacturing process development/improvement
• Equipment Qualification (IQ, OQ, PQ), Validation support
• Root Cause Investigation and development of corrective/preventive action strategies
• Provide technical support and guidance to production associates.
• Ensuring process compliance to ISO 13485:2016 and ISO 9001:2015 standards
• Clearly and effectively communicating with our customers
Critical Success Factors:
• Highly motivated, and comfortable in a fast-paced team environment
• Demonstrated ability to lead and influence others with a quality and customer-first mentality through superior communication skills.
• Hands-on in their approach, actively engaging the production floor.
• 5+ years of Kaizen or Lean Manufacturing experience
• Familiarity with dimensional inspection methods using hand tools, calipers, force gauges, CMM, etc
• Microsoft Office tools
• BS in Mechanical or Industrial Engineering, or related technical field
If you are interested in this Manufacturing Quality Engineer in Boxborough MA, please click APPLY NOW. For other opportunities available at Modis go to www.modis.com. If you have questions about the position, please contact Ben Priest at email@example.com or 503-535-2585.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records.