Principal Product Quality Engineer (Supplier Quality)

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. Our focus on patient outcomes is at the core of everything we do, and our “think I can” attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

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 hybrid work schedules, 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!

ABOUT THIS POSITION

This position must provide expertise and leadership in the areas of corrective and preventive action, manufacturing process controls, warehousing, process assurance, quality system requirements and process monitoring. This position will work with Development, Operations, Manufacturing, and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Partner with Inspire manufacturing team to lead/support Quality Engineering activities with contract manufacturers (IQ, OQ, PQ support, non-conformance resolution, temporary authorities, and deviations).
• Manage, lead, and coach cross-functional teams to resolve quality issues and navigate the CAPA process.
• Drive resolution to non-conformances and deviations, and product hold orders with contract manufacturers. Approve DHRs, DHF deliverables, product releases and ECO.
• Conduct first article inspections (FAIs) on finished medical products.
• Coach Inspire personnel and contract manufacturers on GMP and QMS requirements for medical device manufacturers.
• Lead special projects along with product improvement processes at the direction of quality management.
• Support internal labeling reviews to ensure required markings and symbols are present.
• Partner with data analyst to development performance reporting and visualizations on key quality metrics.
• Partner with internal staff on in-house product repairs, special build requests and project activities (college interns).
• Participate in product performance reviews and emerging quality reviews; support any resulting corrective/preventive actions. Support sterilization activities for Inspire and contract manufacturers. Responsibilities may include sterile lot releases and quarterly bioburden/endotoxin testing.
• Lead supplier audits and support supplier in response actions
• Review and approve supplier change requests
• Support QMS audits with both internal and external auditors
• Ability to perform process and Product Quality assurance functions
• 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.

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required

• Bachelor’s degree in a technical or scientific field.
• 5 - 8 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
• Experience with GHTF requirements for process validations, etc.
• 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

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.
• Experience with Class III active implantables
• Experience with sterilization validation per ISO 11135
• Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
• Experience in design reliability, process and Product Quality assurance functions
• ISO 13485 certified auditor or RAB auditor
• ASQ certifications; CRE, CQM, CQE, CQA etc.

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.

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