Quality Engineer, CAPA Administrator

The role

This person will provide expertise and leadership in corrective and preventive action, manufacturing process improvements, and quality system requirements. They will work with various functional areas to ensure work follows company procedures and geographic regulations.

What you will do

• Manage corrective and preventive action (CAPA) process for internal CAPAs and supplier corrective and preventive action requests (SCARs).
• Lead and coach cross-functional teams to resolve quality issues and navigate the CAPA process.
• Monitor CAPA deliverables, CAPA timelines and trend both CAPAs and SCARs.
• Schedule CAPA team meetings and monthly CAPA management reviews.
• Report on CAPA progress at monthly CAPA meetings and Quality management reviews.
• Support all aspects of CAPA activity including root cause tools, effectiveness checks, and Quality approval for closure.
• Partner with product quality and manufacturing teams to support supplier corrective actions.
• Provide audit support for both the CAPA and SCAR processes.
• Partner with Material Quality to develop SCAR timelines and process monitors.
• Support non-conformance (NCR) process and process trending.

Required qualifications

• Bachelor’s degree in a technical or scientific field.
• 2 - 5 years minimum experience in quality or design function in the finished medical device industry
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects
• Knowledge on ISO and FDA/Quality System Requirements. ( e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
• Strong project and time management skills
• Demonstrated creative and effective problem solving and original thinking for compliance solutions
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with MS Word, Excel and PowerPoint

Nice to have

• Bachelor’s degree in an engineering discipline such as electrical, mechanical, materials, manufacturing or biomedical.
• Master’s degree in a technical or scientific field.
• Experience with Class III active implantables
• Experience with the corrective action process, supplier corrective action requests, nonconformance resolution, field corrective actions and/or product recalls.
• Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
• ISO 13485 certified auditor or RAB auditor
• ASQ certifications; CRE, CQM, CQE, CQA etc.

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• Equity awards
• Employee Stock Purchase Program

About the company

Inspire Medical Systems is a medical device company that designs a device for those living with Obstructive Sleep Apnea (OSA). They are committed to enhancing patients' lives through sleep innovation.