Job Description

Our client, a medical device company advancing the standard of surgical care by pioneering patented instruments, implants, and surgical methods, is expanding their facility footprint and is looking for a senior level Quality Engineer to support their growing business and line of products being developed.

As an integral part of the quality engineering team you will be heavily involved with new product development while working within a collaborative manufacturing environment which will also allow you to impact existing aspects of the business while providing quality oversight.

Required education/experience :

• Bachelor Degree in a relevant technical discipline (engineering/sciences) with 5 years of progressive experience in a quality engineering role within the medical device industry
• Manage design control requirements from product inception through transfer into commercialization
• Create and provide oversight of design history records/files to ensure products meet design control and regulatory requirements
• Create and maintain product and process risk management files to ensure FDA and ISO standards are being met
• Liaison with remote manufacturing and quality vendors to validate product meets desired manufacturability, reliability, and still remains cost effective
• Expertise in quality tools related to manufacturing techniques, processes, and equipment validations
• Ability to interpret drawings to include GD&T annotations
• Working knowledge of 3D modeling software

Preferred education/experience

• Bachelor Degree in Engineering with 5+ years of experience in a Lead or Sr. Design Quality Engineering role within a medical device manufacturing environment
• Certified Quality Engineer or relevant quality systems advanced training
• Expertise in process and equipment validations
• Strong manufacturing process knowledge with background in Design for Manufacturing(DFM) or effects analysis (DFMEA)
• Proven experience leading continuous improvement, Kaizen, or rapid improvement events
• Experience with packaging development or validation testing for ISO 11607
• Participated in FDA, ISO, or internal quality system audits
• Proficiency working in Solidworks or PDM

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