-
Quality Engineer
1 week ago
Interrad Medical Plymouth, United StatesBackground · Interrad Medical, Inc. is a medical device company located in Plymouth, Minnesota. The company designs, develops and manufactures minimally invasive vascular access implantable medical devices for the US and OUS commercial markets. · The Quality Engineer at Interrad ...
-
Quality Engineer
4 days ago
Dynamic Group Minneapolis, United StatesQuality Engineer Dynamic Group Ramsey, MN Dynamic Group is a premier plastic injection molding and mold building company with two locations in the Northwest suburbs of Minneapolis, MN. We provide medical molded parts in our Ramsey location where prod Quality Engineer, Engineer, C ...
-
Quality Engineer
3 days ago
Dynamic Group Minneapolis, United StatesQuality Engineer · Dynamic Group - Ramsey, MN · Dynamic Group is a premier plastic injection molding and mold building company with two locations in the Northwest suburbs of Minneapolis, MN. We provide medical molded parts in our Ramsey location where production runs on 3 shifts ...
-
Quality Engineer
2 weeks ago
Banner Engineering Minneapolis, United StatesWhy Work at Banner? · For over 50 years, Banner Engineering has been at the forefront of some of the biggest industry trends, such as the Industrial Internet of Things (IIoT), and our photoelectric, ultrasonic, and vision sensors, LED lights and indicators, monitoring solutions, ...
-
Quality Engineer
2 days ago
Mactac Minneapolis, United StatesPosition SummaryThe Quality Engineer, under the direction of the remote Quality Assurance Manager, ensures compliance with the company ISO 9001 Quality Management System. The Quality Engineer will support the development, implementation, and maintenance of continuous improvement ...
-
Quality Engineer
2 weeks ago
Banner Engineering Minneapolis, United StatesWhy Work at Banner?For over 50 years, Banner Engineering has been at the forefront of some of the biggest industry trends, such as the Industrial Internet of Things (IIoT), and our photoelectric, ultrasonic, and vision sensors, LED lights and indicators, monitoring solutions, and ...
-
Quality Engineer
2 weeks ago
Integer Holdings Corporation Minneapolis, United StatesBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers' su ...
-
Quality Engineer
2 weeks ago
COGS Minneapolis, United States***QA/QC Manufacturing Engineer***$70,000 - $100,000 DOEWe are helping an industry leading & rapidly growing Aerospace Company as they seek to bring on a driven and ambitious QA/QC Manufacturing Engineer to join the expanding engineering and supply chain function.This opportunity ...
-
Quality Engineer
6 days ago
Dynamic Group Minneapolis, United StatesQuality EngineerDynamic Group - Ramsey, MNDynamic Group is a premier plastic injection molding and mold building company with two locations in the Northwest suburbs of Minneapolis, MN. We provide medical molded parts in our Ramsey location where production runs on 3 shifts throug ...
-
Quality Engineer
3 weeks ago
Spectrum Plastics Master Minneapolis, United StatesJob Details · Level · Experienced · Job Location · SPG Minneapolis - Minneapolis , MN · Position Type · Full Time · Education Level · 4 Year Degree · Travel Percentage · None · Job Shift · Day · Job Category · QA - Quality Control · Quality Engineer · SUMMARY: · Develop ...
-
Quality Engineer
4 days ago
Mactac Minneapolis, United StatesPosition Summary · The Quality Engineer, under the direction of the remote Quality Assurance Manager, ensures compliance with the company ISO 9001 Quality Management System. The Quality Engineer will support the development, implementation, and maintenance of continuous improvem ...
-
Quality Engineer
5 days ago
Mid-Continent Engineering Minneapolis, United StatesJob Description · Job Description · Summary: · Plans & directs activities concerned with development, application, and maintenance of quality standards for processes, materials, and products. Develops, initiates standards & methods for inspection, testing, and evaluation. · Ess ...
-
Quality Engineer
2 weeks ago
ResourceMFG Minneapolis, United Statessummary Select Staffing has a great opportunity for Quality Engineer within a manufacturing company in Chatsworth, CA. Pay: 60,000-75,000 Salary DOE Responsibilities Provide timely resolution to customer inquiries Returned Material Authorization (RMA) coordination and disposition ...
-
Quality Engineer
4 days ago
PSG Global Solutions Careers Minneapolis, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Quality Engineer, working in Biotechnology/Medical Devices industry in 7611 Northland Drive North, Minneapolis, Minnesota, 55428, Unit ...
-
Quality Engineer
2 weeks ago
Wagner Spray Tech Minneapolis, United StatesPosition Objective: · Assure Wagner Spray Tech manufactured materials conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. · Through active participation, support new product development and sustaining engineering a ...
-
Quality Engineer
3 weeks ago
Wagner Spray Tech Minneapolis, United StatesJob Description · Job Description · Position Objective: · Assure Wagner Spray Tech manufactured materials conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. · Through active participation, support new product de ...
-
Quality Engineer
2 weeks ago
Cummins Minneapolis, United States**Quality Engineer** · **Description** · Our culture believes in _POWERING YOUR POTENTIAL_ . We provide global opportunities to develop your career, make your community a better place and work with todays most innovative thinkers to solve the worlds toughest problems. · We bel ...
-
Quality Engineer
3 days ago
PSG Global Solutions Careers Minneapolis, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Engineer, working in Biotechnology/Medical Devices industry in 7611 Northland Drive North, Minneapolis, Minnesota, 55428, United States ...
-
Quality Engineer
2 weeks ago
Konik Inc Minneapolis, United StatesSenior Quality Engineer · Blaine, MN | Contract to Hire | $90k – 115k · Konik is partnering with a local precision machining and sheet metal fabricating company that is seeking a Quality Engineer at their Blaine, MN facility You'll analyze trends, implement improvements, and ensu ...
-
Quality Engineer
2 weeks ago
Wagner Spray Tech Minneapolis, United StatesJob Description · Job Description · Position Objective: · Assure Wagner Spray Tech products conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. · Through active participation and involvement, lead efforts to supp ...
Sr. Product Quality Engineer - Minneapolis, United States - Inspire Medical Systems I
Description
Job DescriptionJob 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 TEAMAt 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 teamABOUT 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
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 resultingcorrective/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.
Required Qualifications
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
Preferred Qualifications
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
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 or email
(dot)com
Inspire Medical Systems participates in E-Verify.
#LI-AM1
#J-18808-Ljbffr