- Partner with Inspire manufacturing team to lead/support quality engineering activities with contract manufacturers (e.g., IQ, OQ and PQ support, non-conformance resolution, temporary authorities, labeling validations, and deviations, etc.)
- Manage non-conformance, deviation, and temporary authorization processes for both contract manufacturers and Inspire.
- Manage, lead, and coach cross-functional teams with contract manufacturers to resolve quality issues and navigate the CAPA process.
- Coach Inspire personnel and contract manufacturers on GMP and QMS requirements for medical device manufacturers.
- Conduct first article inspections (FAIs) on finished medical products.
- Provide expertise on finished device specifications as well as generating and approving ECOs.
- Generate and approve design history file documents, device master record documents and supplier change request records.
- Lead IP development processes for warehouse inspections of new products and revise existing IPs for contract manufacturers as needed.
- Lead contract manufacturer (supplier) audits.
- Support manufacturing risk management activities (i.e., pFMEAs) at suppliers.
- Lead special projects (e.g., dual sourcing, metrics, etc.) along with supplier product improvement processes at the direction of quality management.
- Participate in product performance reviews and emerging quality reviews; support any resulting corrective/preventive actions.
- Support QMS audits with both internal and external auditors.
- Ability to work efficiently and effectively in both a paper-based and electronic QMS.
- Recommend process improvements, driving both efficiency and compliance.
- Bachelor's degree in a technical or scientific field, preferably an engineering discipline
- 5 years minimum experience in medical device
- 5 years minimum experience in a product, manufacturing quality (process), material or component quality engineering position
- Knowledge of ISO and FDA Quality System Requirements (e.g., ISO 13485; FDA 21 CFR Part 820)
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Experience with engineering tools such as; dFMEA, pFMEA, SPC, etc.
- Working knowledge of process improvement techniques such as Six Sigma, Lean Sigma, Proof of Station, etc.
- 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 of MS Word, Excel and PowerPoint
- Master's degree in a technical or scientific field
- Experience in component, manufacturing quality (process) and product quality assurance functions
- Experience in design assurance or quality systems functions.
- Experience with 21 CFR 820, ISO 13485, ISO 14971, European Directives and European Regulations
- Experience with SPC software tools
- Experience with engineering tools such as; DOE, FTA, GHTF requirements for process validations, etc.
- ISO 13485 certified auditor or RAB auditor
- ASQ certifications; CRE, CQM, CQE, CQA etc.
- ISO 14971 training
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Sr. Product Quality Engineer - Golden Valley, United States - Inspire Medical Systems, Inc.
Description
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 finished medical device manufacturing, product inspection/test, manufacturing process monitoring and control implementation, sterilization, labeling, supplier development, audit and supplier management. This person is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance. This position will work with Development, Operations, Manufacturing, Regulatory 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
Required Qualifications
Preferred Qualifications
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 anequal opportunityemployer 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 or email (dot)com
Inspire Medical Systems participates in E-Verify.
#LI-AM1
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 with regard to 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 are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at or email
