Quality Systems Engineer: Medical Device Compliance & Audits

Cretex Medical Component and Device Technologies

Cretex Medical is seeking a Quality Systems Engineer to support and administer the QMS across ISO 9001, ISO 13485, and FDA QSR requirements. You will lead internal and supplier audits, develop corrective actions, and drive continuous improvement through data analysis and BI-driven insights. Responsibilities include documenting changes, training, and ensuring regulatory compliance. A Bachelor’s degree in a STEM field and 5+ years’ experience in regulated environments are required. #J-18808-Ljbffr

Apply

Vacancy posted 5 days ago

Similar jobs that could be interesting for youBased on the Quality Systems Engineer: Medical Device Compliance & Audits in Minneapolis, MN vacancy

Quality Engineer II: Medical Device QC & CAPA
Jabil is seeking a Quality Engineer II to ensure product quality and process compliance in medical device manufacturing. You will apply engineering principles and quality tools... ...continuous improvement and robust quality systems. The role supports R&D, manufacturing, and...
Suggested
Jabil
Osseo, MN
5 days ago
Onsite Failure Analysis Engineer I — Medical Devices
...seeking a Failure Analysis Engineer I in Plymouth, MN to... ...investigations of returned medical devices, performing electrical, functional... ...in complaint handling systems to ensure audit-ready reports. A bachelor'... ...experience with regulated quality systems are required. #J-...
Suggested
Experis Technology Group
Minneapolis, MN
1 day ago
Senior Principal Software Engineer Medical Device Compliance
...software lifecycle for regulated medical device software. You will drive SDP,... ...with Regulatory Affairs and Quality to meet global submissions. You... ..., select tech stacks, mentor engineers, and lead verification/validation across complex systems while aligning with cross-functional...
Suggested
LogiSolve
Minneapolis, MN
3 days ago
Sr. Principal Lead/Architect/Engineer Workload Automation (IBM Tivoli-TWS/IWS)
$50 - $60 per hour
...EngineerSr. Principal Lead/Architect/Engineer Workload Automation (IBM... ...tooling.Own security and compliance posture: access model (LDAP/SSO... ...), least-privilege controls, audit evidence, vulnerability... ...dynamic scheduling, JSDLOperating Systems: Linux, UNIX (AIX/SunOS), Windows...
Suggested
Hourly pay
Weekend work
SRI Tech
Minneapolis, MN
5 days ago
Quality Engineer I - Medical Devices (Contract)
Primary Talent Partners has a new contract opening for a Quality Engineer I with our medical device client in Plymouth, MN. This is a 12-month contract... ...implementing testing and inspection processes to ensure compliance and reliability across production lines. #J-18808-...
Suggested
Contract work
Primary Talent Partners
Minneapolis, MN
4 days ago
QA Validation Engineer - Medical Devices PQ & Method
...Healthcares- is seeking a QA Validation Engineer to support quality assurance, process validation, and... ...method validation in a regulated medical device environment. The candidate will apply... ...work with CAPA processes to maintain compliance. The role requires hands-on...
Katalyst-Healthcares-
Minneapolis, MN
4 days ago
Senior Director, Tax Compliance & Audit
$192k - $275k
ABOUT INSPIRE MEDICAL SYSTEMSInspire is the... ...its kind medical device designed to make a... .... Inspire Medical Systems is committed to enhancing... ...accounting, tax compliance, tax planning,... ...assessments.Manage tax audits, controversies,... ...initiatives.QUALITY SYSTEM RESPONSIBILITIES...
Permanent employment
Work experience placement
Local area
Flexible hours
Inspire Medical Systems
Minneapolis, MN
7 days ago
Senior Supplier Quality Engineer - MedTech Compliance Lead
...Plymouth, MN is seeking a Sr. Supplier Quality Engineer to lead product assurance for... ...documentation to manufacturing, ensuring compliance with FDA and ISO standards. The ideal... ...quality or manufacturing quality within medical devices, strong communication, #J-18808-...
HistoSonics, Inc.
Minneapolis, MN
3 days ago
Quality Assurance Specialist - ISO/Regulatory Audits
...Sourcing Group, LLC is seeking a Quality Assurance professional to support laboratory compliance with ISO/IEC 17025, ISO 13485... ...The role involves coordinating audits, CAPA activities, and ensuring inspection readiness in a medical device or regulated setting. The ideal...
Veterans Sourcing Group LLC
Saint Paul, MN
5 days ago
Manufacturing quality engineering
$80k - $100k
...Job Title: Quality Engineer Job Description The Quality... ..., and ensures compliance with ISO, FDA, and other... ...maintain robust quality systems and support... ...internal and external audits to verify compliance... ...environment, such as medical devices. Proficiency in process...
Permanent employment
Full time
Temporary work
Part time
Casual work
Flexible hours
Actalent
Minneapolis, MN
4 days ago
Systems Engineer (medical devices)
...Remote50% RemoteSummaryThe Systems Engineer will support the overall technical... ...within a regulated medical device environment.Roles & Responsibilities... ...inputs (regulatory, quality, manufacturing, service,... ...teams and stakeholdersEnsure compliance with FDA, ISO, and IEC design...
Katalyst Healthcares & Life Sciences
Minneapolis, MN
5 days ago
Quality Engineer Intern (Medical Devices)
...Cretex Medical in Bloomington, MN invites you to join as a Quality Engineer Intern. The role supports the Quality team on projects... ...engineering fundamentals in a medical device environment. You’ll read... ...complying with ISO and Quality System requirements. #J-18808-Ljbffr
Internship
Regulatory Jobs
Bloomington, MN
5 days ago
Senior NPD Process Engineer - Medical Devices
...seeking a Principal New Product Development Process Engineer to transform new medical device concepts into scalable manufacturing processes.... ...transfer with cross-functional teams to ensure quality and regulatory compliance. You will mentor engineers, drive process...
Automatic Data Processing
Minneapolis, MN
12 hours ago
Remote-Eligible Validation Specialist (GMP/GLP)
...environment. You will perform risk assessments, assist with audits, and maintain compliance with SOPs and regulatory guidelines. The role requires a... ...at least 2 years of experience in validation or process engineering within GLP/GMP environments, with strong proficiency in...
Remote work
Harvard Bioscience
Saint Paul, MN
5 days ago
Financial Accountant
...Financial AccountantSaluda Medical is a commercial-stage medical device company focused on... ...first product, the Evoke® System, is designed to deliver known... ...accounting, reporting, and compliance activities and plays a... ...reconciliations.Assist with external audits, tax compliance...
Saluda Medical
Minnetonka, MN
3 days ago
Quality Engineer II- Medical Devices
$68.8k - $123.8k
...offering comprehensive engineering, supply chain,... ...an impact? The Quality Engineer II at... ...quality and process compliance through the... ...involves supporting medical device manufacturing operations... ...robust quality systems. What will you do... ..., including audits, qualification, and...
Work at office
Local area
Worldwide
Jabil
Osseo, MN
5 days ago
Senior Project Manager, Clinical Risk Evaluation
$78k - $156k
...in diagnostics, medical devices, nutritionals and... ...glucose monitoring systems, innovative... ...hearts, improve quality of life for thousands... ...Clinical R&D, Quality Engineering, regulatory... ...sustaining teams. Compliance with applicable... ...internal and external audits and responses to...
Work experience placement
Worldwide
Abbott
Saint Paul, MN
8 days ago
Compliance Engineering
...GRC Engineer United States (Remote) Ideally east coast Have... ...environment? Do you approach compliance like an engineer, automating,... ..., and embedding it into systems? My client is one of the... ...early-stage build through to audit readiness and certification...
Remote work
Iceberg
Minneapolis, MN
2 days ago
Sr. Regulatory Affairs Manager
...submissions. This individual will ensure compliance with all applicable regulations in the... ...approval and launch of innovative medical devices. Responsibilities: Prepare, review,... ...in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred...
Katalyst Healthcares & Life Sciences
Minneapolis, MN
8 days ago
Technical Advisor - Biocompatibility/Chemistry
$90k - $110k
...progress. We test, we audit, we inspect, we... ...Technical Advisor, Medical Device Testing - Biocompatibility... ...the right testing and compliance solutions for their medical... ...aligned with TÜV SÜD quality and technical... ...Bachelor's degree in Engineering, Life Sciences, Chemistry...
Full time
Contract work
Local area
Remote work
Tüv Süd Ag
New Brighton, MN
2 days ago
Security Compliance Engineer
...Job Title: Security Compliance Engineer Location: Remote Job description - Must Have Technical/Functional Skills • DISA STIG and SRG experience. • SCAP tooling and STIG Viewer. • Federal RMF / ATO process knowledge. • Security hardening for RHEL and Windows Server environments...
Remote work
Ztek Consulting
Minneapolis, MN
4 days ago
Head of Clinical Trials Neurotech & Brain Health (Remote)
...A cutting-edge medical device startup is seeking a Head of Clinical to lead the clinical strategy for a neurostimulation device targeting... ...trials, managing day-to-day operations, and ensuring regulatory compliance. Ideal candidates will have 7+ years in clinical research for...
Remote work
NeuraWorx
Minneapolis, MN
2 days ago
Quality Technician - Ensure Safe Medical Devices & Compliance
...Laborie seeks a Quality Technician to join our Quality team. This role focuses on planning and conducting QA activities to assure processes... ..., and products meet required standards and support Quality Systems. You will perform inspections at various stages, document...
Laborie
Minneapolis, MN
5 days ago
In-House Counsel / Regulatory (Life Sciences)
...A prominent Massachusetts-based medical device leader is seeking a Regulatory Counsel... ...legal advice on regulatory and quality matters. The role involves managing compliance with international regulations,... ...regulatory strategy, supporting audits and inspections, and guiding...
New England Legal Search Ltd.
Minneapolis, MN
3 days ago
Global Strategic Sourcing Manager - Medical Devices
...Trelleborg Medical Solutions is seeking a Strategic Sourcing Manager to lead a global purchasing team in Plymouth, Minnesota. You will drive spend analysis, develop global commodity strategies, and negotiate contracts with key suppliers for critical raw materials. The...
Trelleborg Group
Minneapolis, MN
2 days ago
Test Development Engineering
$100k - $130k
...technical and sustaining engineering support in the... ...fabrication process is in compliance. Recommends and helps... ...yield loss and improving quality. Interacts with... ...hardware capability.Review device specifications and look... ...test or reliability test system is a plus....
Permanent employment
Full time
Summer work
Polar Semiconductor
Minneapolis, MN
5 days ago
Software Quality Engineer II (Reliability/ Compliance)
$81.6k - $122.4k
...developing innovative medical technologies that... ...work together to engineer the extraordinary.... ...as a Software Quality Engineer II and be... ...electrophysiology systems. By blending technical... ...for quality, compliance, and improving patient... ...skills. Medical device or other regulated...
Full time
H1b
Work at office
Local area
Immediate start
Worldwide
Flexible hours
Medtronic
Saint Paul, MN
5 days ago
Director of Process Quality & Center of Excellence
...Philips in Plymouth, MN seeks a Director, Process Compliance & Centers of Excellence to lead enterprise quality controls and process improvements across sites.... ...-based role requires 10+ years in FDA-regulated medical devices and leadership in global matrixed organizations....
Work at office
Philips
Minneapolis, MN
3 days ago
Senior Design Quality Engineer - Cardiac Rhythm Diagnostics
...Scientific Arden Hills, MN is seeking a Principal Design Quality Engineer to support active implantable medical devices. You will collaborate with R&D, process... ...affairs to ensure safety, high quality, and regulatory compliance throughout the lifecycle. This hybrid role...
Work at office
Relocation package
3 days per week
Boston Scientific
Arden Hills, MN
2 days ago
Hardware Quality Engineering
$75k - $112.6k
...About Cretex Medical Cretex Medical is a leading... ...assemblies for the medical device industry. Our... ...Position Summary The Quality Systems Engineer will be responsible for... ...enabling enterprise level compliance. This position is... ...Standards Library, Internal Audit, New Customer Audit,...
Hourly pay
Contract work
Temporary work
Work at office
Local area
Cretex Medical Component and Device Technologies
Minneapolis, MN
5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Systems Engineer: Medical Device Compliance & Audits. Be the first to apply!