Quality Engineer, CAPA Administrator
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Key details
- Salary
- $70K–$90K/yr
- Location
- Minneapolis, MN, United States
- Work style
- Onsite
- Level
- Mid level
- Experience
- 2–5 yrs
- Function
- Hardware, mechanical & civil engineering
- Focus area
- other
- Posted
- 2w ago
Skills
About the role
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
POSITION SUMMARY
This position must provide expertise and leadership in the area of corrective and preventive action, manufacturing process improvements, quality system requirements and process monitoring. This position will work with Development, Manufacturing, Marketing, Information Systems and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations. This role must be flexible for changing priorities and able to work without direct supervision.
MAIN DUTIES/RESPONSIBILITIES
- Manage corrective and preventive action (CAPA) process for both internal Inspire CAPAs as well as 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 as well as Quality management reviews.
- Support all aspects of CAPA activity, including CAPA owner assignment, utilization of root cause tools (i.e., 5 whys, Is/Is Not, Ishikawa, etc.), verification of effectiveness checks and Quality approval for CAPA closure.
- Partner with Inspire 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.
- Participate in the development of quality work instruction and procedural updates as assigned.
QUALITY SYSTEM RESPONSIBILITIES
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
QUALIFICATIONS
Educational Requirements:
Required
- Bachelor’s degree in a technical or scientific field.
Preferred
- Bachelor’s degree in an engineering discipline such as electrical, mechanical, materials, manufacturing or biomedical.
- Master’s degree in a technical or scientific field.
Required Experience:
- 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) </
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