Quality Systems Leader - Medical Devices & ISO 13485

Nextern

NPX Medical, a division of Nextern, is seeking a Quality Systems Manager to lead the Quality Management System, align with regulatory agencies, and coordinate global initiatives. The role oversees CAPA, Change Control, Document Control, and audits to ensure product quality and regulatory conformity. The ideal candidate has a STEM degree with 7+ years in ISO 13485 and FDA GMP, and 2+ years in quality management, plus strong communication skills. #J-18808-Ljbffr Nextern

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the Quality Systems Leader - Medical Devices & ISO 13485 in Osseo, MN vacancy

Quality Systems Manager
$120k - $160k
...Job Description NPX Medical is a division of... ...integrated medical device development and manufacturing... ...fully integrated systems to precision... ...worldwide. The Quality Systems Manager will... ...Medical and their ISO notified body. Directly... ...experience in ISO 13485 and FDA GMP. ~2+...
Quality
Medical device
Temporary work
Worldwide
Nextern
Osseo, MN
5 days ago
Quality Engineering Senior
...Senior Quality Systems Engineer The Senior Quality Systems Engineer... ...standards, including FDA QMSR, ISO 13485, ISO 14971, and EU MDR.... ...+ years of experience in a medical device manufacturing, quality or... ...work independently, as a team leader or member, and enjoy being...
Quality
Medical device
Work at office
3 days per week
Intracept by Boston Scientific
Maple Grove, MN
5 days ago
Quality Engineering Senior
...Spencer Gregory HaleSenior Quality Systems EngineerAbout the role:The... ...standards, including FDA QMSR, ISO 13485, ISO 14971, and EU MDR.... ...+ years of experience in a medical device manufacturing, quality or regulatory... ...independently, as a team leader or member, and enjoy being...
Quality
Medical device
Hourly pay
Work at office
Shift work
3 days per week
Boston Scientific Corporation
Osseo, MN
3 days ago
Quality Engineering Senior
$85k
...This Role : The Senior Quality Systems Engineer of material controls... ..., ensuring compliance to Medical Device regulations and BSC Quality... ...processes, FDA regulations, ISO 13485, and Medical Device... ...global medical technology leader for more than 45 years, we...
Quality
Medical device
Hourly pay
Work at office
Local area
Relocation package
Shift work
3 days per week
Boston Scientific
Maple Grove, MN
1 day ago
Quality Technician (Medical Device - ISO 13485)
...be the premier choice in the medical custom sewn products market,... ...and the steadfast belief in quality over quantity, we will be the... ...procedures and Quality Management System. · Maintain TPI's approved... ...experience in manufacturing ISO 13485. · Experience with...
Quality
Medical device
Work at office
Titus Talent Strategies
Andover, MN
a month ago
Quality Systems Specialist
...Quality Systems Specialist Integrated Resources, Inc is a premier staffing firm recognized... ...or auditing experience Previous medical device or other regulated industry experience... ...Quality System Regulation (21CFR820), ISO 13485:2003, and CFR Parts 210 and 211. Solid...
Quality
Medical device
Integrated Resources
Minneapolis, MN
3 days ago
Quality Systems Engineer
$75k - $112.6k
...Overview About Cretex Medical Cretex Medical is a leading... ...assemblies for the medical device industry. Our customers... ...Position Summary The Quality Systems Engineer will be responsible... ...to requirements outlined in ISO 9001, ISO 13485, and/or FDA QSR. Active...
Quality
Medical device
Hourly pay
Contract work
Temporary work
Work at office
Local area
Cretex
Minneapolis, MN
3 days ago
Testing Systems Engineering
$36 per hour
...Duties Now Hiring: Systems Test Engineer Location... ...testing of innovative medical technology products. This... ...including Engineering, Quality, Regulatory, and... ...physiology, and medical device applications is a plus.... ...experience. Knowledge of ISO 13485, ISO 14971, Design...
Quality
Medical device
Hourly pay
Full time
Temporary work
For contractors
Internship
Local area
Immediate start
Shift work
Advantage Technical
Osseo, MN
5 days ago
Quality Assurance Officers
...Quality Systems Specialist As a ProMed employee, you will contribute to... ...specifically those having a medical application. We treat every component and finished device as though it will be used by... ...organization compliant with ISO 13485, FDA 21 CFR 820, and 21 CFR...
Quality
Medical device
Work at office
ProMed Molded Products
Minneapolis, MN
1 day ago
Systems Engineer (medical devices)
...79Remote50% RemoteSummaryThe Systems Engineer will support the overall... ...within a regulated medical device environment.Roles & Responsibilities... ...inputs (regulatory, quality, manufacturing, service, etc.... ...stakeholdersEnsure compliance with FDA, ISO, and IEC design control...
Quality
Medical device
Katalyst Healthcares & Life Sciences
Plymouth, MN
3 days ago
Quality Control Checker - 2nd Shift
$18.22 - $27.84 per hour
...About Cretex Medical Cretex Medical is a leading contract... ...for the medical device industry. Our customers... ...Learn more at Summary Quality Inspector Position Summary... ...the company's Quality System, ISO, and medical device requirements... ...Knowledge of ISO 9001/13485 Quality training/...
Quality
Medical device
Hourly pay
Contract work
Temporary work
Work at office
Local area
Monday to Friday
Shift work
Afternoon shift
Cretex
Brooklyn Park, MN
2 days ago
Quality Control Manager
$100.9k - $151.3k
...About Cretex Medical Cretex Medical is a leading... ...for the medical device industry. Our... ...assembly. Learn more at Quality Control Manager... ...‑on technical leader who can set direction... ...Quality Management System. Ensure inspection... ...21 CFR 820 and ISO 13485 knowledge. 5+ years...
Quality
Medical device
Contract work
Shift work
Cretex
Brooklyn Park, MN
3 days ago
Principal Manufacturing Engineer
...Manufacturing Engineer NPX Medical is a division of Nextern... ...integrated medical device development and... ...manufacturing methods, systems and processes to produce a high-quality product. Responsibilities... ...with FDA regulations and ISO 13485 standards. Design, develop...
Quality
Medical device
Nextern Inc.
Maple Grove, MN
3 days ago
Principal Quality Systems Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)
...About the role:This Principal Quality Systems Engineer serves as a Design... ...of work experience in the medical device or other regulated... ...including 21 CFR 806 & 820, ISO 13485:2016Project management experienceExperience... ...global medical technology leader for more than 45 years, we...
Quality
Medical device
Hourly pay
Work experience placement
Work at office
Local area
Relocation package
Shift work
3 days per week
Boston Scientific Corporation
Arden Hills, MN
4 days ago
Site Quality Leader
$149.3k - $298.7k
...is a global healthcare leader that helps people live... ...in diagnostics, medical devices, nutritionals and branded... ...scientistsThe OpportunityThe Site Quality Leader is the senior... ...Heart Quality System. In addition, the position... ...EU MDR, FDA QMSR, ISO 13845Maintain continuous...
Quality
Medical device
Shift work
Abbott
Plymouth, MN
4 days ago
Quality Systems Specialist
$75.2k - $112.8k
...Medtronic is a global leader in healthcare... ...developing innovative medical technologies that... ...Provides Quality System support and guidance... ...Administration) Medical Device Directives/... ...Privacy Act) and ISO (International Organization... ...GMP, QSR and ISO 13485, and MDSAP) for...
Quality
Medical device
Full time
H1b
Work at office
Local area
Immediate start
Flexible hours
Medtronic
Minneapolis, MN
1 day ago
Quality Engineering Senior
...are urgently seeking a Senior Quality Engineer with strong hands-... ...experience in FDA-regulated medical device manufacturing.Roles &... ...regulated environments & Quality Systems.Hands-on Technology/Product/... ...& CAPA.Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk...
Quality
Medical device
Contract work
Katalyst Healthcares & Life Sciences
Brooklyn Park, MN
6 days ago
Site Quality Leader
$149.3k - $298.7k
...Abbott seeks a Site Quality Leader for its Plymouth, MN structural heart... ..., oversees quality systems, and leads the quality organization... ...with FDA QMSR, EU MDR, and ISO 13485 standards Lead and... ...field Minimum 12 years medical device manufacturing experience with...
Quality
Medical device
Abbott
Plymouth, MN
10 days ago
Quality Technician - 1st shift
$23.08 - $36.49 per hour
...About Cretex Medical Cretex Medical is a... ...assemblies for the medical device industry. Our... ...summary The Quality Technician will be... ...scope, CMM, and vision systems Effective... ...company Quality System, ISO, and medical device... ...of ISO 9001/13485 ~ Quality certifications...
Quality
Medical device
Hourly pay
Contract work
Temporary work
Local area
Shift work
Day shift
Cretex
Brooklyn Park, MN
2 days ago
Sr Systems Engineer
...Sr Systems Engineer :: Minneapolis Minnesota 55432 Contract :: 12+ Months Skillsets... ...and testing. ~ Previous medical device experience with a history of... ...working with and designing systems to meet ISO and Quality System Regulation requirements, including...
Quality
Medical device
Contract work
Infotree Global Solutions
Minneapolis, MN
3 days ago
Manufacturing Engineering Planning
$80k - $110k
...and manufacture world-class medical devices across the full product lifecycle... ...to fully integrated systems to precision components, our... ...production while maintaining quality standards Write, review,... ...compliance with FDA regulations and ISO 13485 standards Design,...
Quality
Medical device
Temporary work
Worldwide
Nextern Inc.
Maple Grove, MN
3 days ago
Quality Engineering Senior
...Our client, a growing medical device company, is seeking a Supplier Quality Engineer to support supplier quality management... ...meet regulatory and quality system requirements. The ideal candidate... ...Ensure supplier processes align with ISO 13485 and medical device regulatory...
Quality
Medical device
Custom Search
Maple Grove, MN
4 days ago
Quality Engineer II- Medical Devices
$68.8k - $123.8k
...will you make an impact? The Quality Engineer II at Jabil/Nypro... ...role involves supporting medical device manufacturing operations, driving... ...maintaining robust quality systems.What will you do?* Develop,... ...quality standards (e.g., ISO 13485, IATF 16949).* Collaborate...
Quality
Medical device
Full time
Work at office
Local area
Worldwide
Jabil
Maple Grove, MN
5 days ago
Production Supervisor - 3rd Shift
...high standards for safety, quality, delivery, and efficiency.... ...production information in ERP systems Lead projects and cross-functional... ...maintain compliance with ISO and medical device quality requirements... ...knowledge of ISO 9001 and/or ISO 13485 Experience in a...
Quality
Medical device
Work at office
Shift work
Night shift
Weekend work
IntePros
Brooklyn Park, MN
5 days ago
Indirect Category Lead
...closely with Operations, Engineering, R&D, Quality, Finance, Regulatory, Manufacturing,... ...certification. Experience within medical device, life sciences, healthcare, pharmaceutical... ...manufacturing industries. Knowledge of ISO 13485, FDA, or other regulated industry requirements...
Quality
Medical device
Contract work
Visa sponsorship
Work visa
Flexible hours
Laborie Medical Technologies Corp.
Osseo, MN
1 day ago
Quality Systems Specialist
$75.2k - $112.8k
...Quality Systems Specialist role at Medtronic supporting medical device compliance across FDA and international regulatory frameworks... ...ensuring adherence to GMP and ISO standards for surgical operating... ...Knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP medical device regulations...
Quality
Medical device
Medtronic
Minneapolis, MN
6 days ago
Senior Systems Engineering
...activities associated with the systems engineering of one or... ..., human factors, quality, manufacturing,... ...Drive adherence to FDA, ISO and IEC design control... ...discipline Prior experience in medical devices, preferably for... ...collaboration with project leaders Creative Problem...
Quality
Medical device
Remote work
Shift work
Katalyst Healthcares & Life Sciences
Plymouth, MN
6 days ago
Principal Manufacturing Engineer
...creating strategies and systems which allow all Laborie... ...compliance with ISO standards and robust process... ...Improve product and process quality by defining testing... ...Master's), preferably in medical device industry; Bachelor's in... ...knowledge of ISO 13485/ISO 9000 standards, health...
Quality
Medical device
Work at office
Flexible hours
Laborie Medical Technologies Corp
Maple Grove, MN
1 day ago
Quality Engineer II- Medical Devices
$68.8k - $123.8k
...will you make an impact? The Quality Engineer II at Jabil/Nypro... ...This role involves supporting medical device manufacturing operations,... ...maintaining robust quality systems. What will you do? Develop,... ...relevant quality standards (e.g., ISO 13485, IATF 16949). Collaborate...
Quality
Medical device
Work at office
Local area
Worldwide
Jabil
Osseo, MN
3 days ago
Computer Systems Validation Engineer
...Job title : Computer Systems Validation Engineer-12345 Job Description:... ...About This Role: To ensure the quality of our client's software applications and... ...direct experience ~ Experience in Medical Device manufacturing specifically writing compliance...
Quality
Medical device
Three Point Solutions
Maple Grove, MN
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Systems Leader - Medical Devices & ISO 13485. Be the first to apply!