We are searching for a Quality Engineer with medical device experience to lead quality activities for a company that makes medical device precision components. You will support all department activity with a focus on quality management compliance – QMS.
Requirements for the Quality Engineer – Medical Devices:
- Bachelor’s degree in engineering, preferably mechanical engineering
- 5+ years’ experience in quality control, assurance, and engineering environment.
- Working experience with ISO 13485, FDA ISO regulations
- Experience with Inspection Metrology / GD&T / MSA / manufacturing processes and engineering drawings.
- Experienced with machine shop and manufacturing
- The ability to travel both domestically and internationally up to approximately 20%.
- Process validation experience and involvement preferred
- Complaint handling – CAPA – experience preferred
- Experience with a variety of component manufacturing, production, and qualification, and validation test processes related to machining, welding casting, molding, stamping, forging, painting, plating, heat treating, assembly, and fabrication preferred.
- PPAP, CAPA, RCCA, 8D, DMAIC, PDCA, SPC, GD&T, LSS, ISO 13485, ISO 9001, and Lean Manufacturing trained and experience, preferred
- Mechanical aptitude for working with tools to perform assembly and testing of the product, preferred
- ASQ CQE preferred
Responsibilities of the Quality Engineer – Medical Devices:
- Lead and document quality systems enhancements for device compliance and involvement with customer and factory teams to meet expectations, process, and manufacturing commitments.
- Lead and mentor factory team’s development of their quality management systems to align with FDA & SRI requirements.
- Track and evaluate factory performance to determine the action required for development and improvement.
- Champion activity to resolve customer product complaints and issues related to non-conformances.
- Lead in-house and factory problem-solving / troubleshooting activity to resolve issues and implement improvement actions for effective long-term problem elimination and increased manufacturing efficiency.
- Travel to factories when necessary, (APAC region and where required), to support production and supply base development, including factory assessment, audits, training, and improvement follow-up.
: Please apply using the form or send your resume to Debbie Winkelbauer