Senior Quality Engineer

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 industryManage design control requirements from product inception through transfer into commercializationCreate and provide oversight of design history records/files to ensure products meet design control and regulatory requirementsCreate and maintain product and process risk management files to ensure FDA and ISO standards are being metLiaison with remote manufacturing and quality vendors to validate product meets desired manufacturability, reliability, and still remains cost effectiveExpertise in quality tools related to manufacturing techniques, processes, and equipment validationsAbility to interpret drawings to include GD&T annotations Working knowledge of 3D modeling softwarePreferred education/experienceBachelor Degree in Engineering with 5+ years of experience in a Lead or Sr. Design Quality Engineering role within a medical device manufacturing environmentCertified Quality Engineer or relevant quality systems advanced trainingExpertise in process and equipment validationsStrong manufacturing process knowledge with background in Design for Manufacturing(DFM) or effects analysis (DFMEA)Proven experience leading continuous improvement, Kaizen, or rapid improvement eventsExperience with packaging development or validation testing for ISO 11607Participated in FDA, ISO, or internal quality system audits Proficiency working in Solidworks or PDM

Created: 2025-02-19