- Lead supplier qualification, supplier approval and component qualification process.
- Lead CFI and IP development processes for new and existing components.
- Provide expertise on component specifications as well as generating and approving ECOs.
- Lead supplier audits and manage supplier CAPA activities.
- Lead incoming component receipt activities and generate/manage MR requests as needed.
- Support process assurance activities (i.e.; manufacturing verification and validation).
- Support manufacturing risk management activities (i.e.; pFMEAs).
- Lead annual supplier reviews and support Operations in supplier quarterly business reviews.
- Generate and approve design history file documents, device master record documents and supplier change request records
- Lead/support cross-functional teams to resolve quality issues and complete CAPAs.
- Complete component incoming inspections as needed and manage external vendors for outsourced inspection activities.
- Develop and manage supplier metrics and scorecards using SPC tools as well as business intelligence tools (i.e., Power BI)
- 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
- 5-10 years minimum in experience in a material or component quality 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 material, component, process and product quality assurance functions
- Experience with 21 CFR 820, ISO 13485, ISO 14971, European Directives and/or 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. Material 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 component manufacturing, component inspection and supplier quality 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, Post Market Surveillance and other functional areas globally to ensure work is completed in accordance with Inspire procedures and geographic regulations. In addition, this role must be flexible for changing priorities, able to work without supervision and manage other personnel in the future.
The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management.
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
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