Quality Engineer II/III - QMS, ISO 13485 & FDA
ATL Technology, LLC
A leading provider of medical device solutions in Maple Grove, MN is looking for a Quality Engineer II/III. The ideal candidate will ensure compliance with regulatory obligations including ISO and FDA requirements, improve Quality Management Systems, and work collaboratively with cross-functional teams on quality initiatives. The role offers competitive salary and benefits including medical, dental, and a generous 401k plan. Join us in our mission to enhance the quality of medical devices. #J-18808-Ljbffr ATL Technology, LLC
- **Quality Engineer II/III**The Quality Engineer with have a great aptitude for... ...compliance requirements of ISO and the FDA.**What you will be doing:**... ...Quality Management Systems (QMS), contribute to audits and... ...understanding of the elements of ISO 13485 QMS processes and USA FDA...SuggestedContract workWork at officeLocal areaRemote work
$61.3k - $122.7k
Quality Engineer II The Opportunity This position works out of our Minnetonka... ...Quality Management Systems (QMS), Environmental Management Systems... ...and Drug Administration (FDA) regulations, other regulatory... ...knowledge of FDA, GMP, ISO 13485, and ISO 14971. Ability to...SuggestedWork experience placement- ...United States Job type: Contract Quality Assurance Engineer - Medical Device Northwest... ...audits as Subject Matter Expert (SME) for QMS processes and product DHFs Drive Product... ...systems as defined in 21 CFR 820 and ISO 13485 ~ Background as a development...SuggestedContract workWork at office
- ...responsible for operational quality input and deliverables for manufacturing... ...lifecycle. Quality Assurance Engineers will also support development... ...Matter Expert (SME) for QMS processes and product DHFs.... ...as defined in 21 CFR 820 and ISO 13485. · Development project...SuggestedTemporary work
- A global healthcare company in Minnetonka, MN is seeking a Quality Engineer II to support sustainability of products and ensure manufacturing... ..., 2-5 years of relevant experience, and knowledge of FDA and ISO standards. Responsibilities include implementing process control...Suggested
$71.5k
Recruiter: Spencer Gregory Hale Supplier Quality Engineer - Direct Materials Acquisitions About the role:The Global Sourcing organization... ...commodity team. Lead auditor of quality systems experience (ISO 13485 or similar). ASQ certification (CQE, CBA, SSGB, SSBB)...Hourly payFull timeShift work$129.3k - $258.7k
Senior Manager, Quality Engineering - Minnetonka MN Abbott is a global healthcare... ..., mission and vision and FDA/ISO regulations; it assures the... ...requirements. Class III or II medical device background in... ...Regulations knowledge (ISO 9001, ISO 13485). Ability to work in a...Work experience placementImmediate start- Design Quality Engineer III — Medical Device (Onsite — Maple Grove, MN) Contract Maple Grove, United States | Posted on 04/30/2026 Job Description Our F500 Medical Device client has an exciting opportunity for a Design Quality Engineer III. Job Summary: Develops, establishes...Contract work
$90.4k - $147.4k
...Join the world's largest HVAC company, named by Forbes as one of America's Best-In-State Employers 2025! NPI Quality Assurance Engineer III Make your mark at the world's largest HVAC company Daikin Applied is seeking an NPI Quality Assurance Engineer III...Work at officeLocal areaOverseas- ...Develops, establishes, and maintains software quality assurance methodologies, systems, and... ...a team of Software Quality Assurance Engineers that support manufacturing, laboratory, R... ...Software Quality Assurance activities in an FDA-regulated medical device environment and...Work experience placement
$100k - $125k
...Quality Assurance Engineer Job Description: This role is responsible for providing operational... ...audits as Subject Matter Expert (SME) for QMS processes and product DHFs. Drive... ...quality systems as defined in 21 CFR 820 and ISO standards ~ Development project team...Permanent employmentTemporary work$61.3k - $122.7k
Supplier Quality Engineer II This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart...Work experience placement$76k - $141.1k
...the primary bridge between our customers, engineering teams, and global supply base, ensuring... ...program teams, and suppliers to resolve quality issues and ensure seamless delivery.* **Build... ...* CQE, CMQ, CQA, or APQP.* **Auditing:** ISO 9001:2015 Internal Auditor training.* **...Minimum wageFull timeTemporary workWork at officeLocal areaWorldwideFlexible hours- A leading global healthcare company is seeking a Supplier Quality Engineer II in Minnetonka, MN to assess suppliers and ensure quality standards. The successful candidate will possess a Bachelor’s Degree and a minimum of 2 years’ experience in quality assurance. This role...
$61.3k - $122.7k
Abbott Laboratories is seeking a Quality Engineer II for their Minnetonka, MN location. This role involves ensuring product quality and compliance with FDA and GMP standards, leading process optimizations, and collaborating with cross-functional teams. Candidates should...Afternoon shift$50 per hour
...is seeking a Software Test Engineer to join their team. As a Software... ...software in accordance with FDA, EU-MDR, and ISO standards. Contribute to... ...of testing procedures and quality assurance practices. What... ...Part 820, EU-MDR, and ISO 13485. If this is a role...Hourly pay$70k - $90k
Quality Engineer Medica USA is looking for a motivated Quality Engineer. The candidate will understand how to identify nonconforming products... ...well as operations in accordance with 21 CFR regulations / ISO 13485. Responsibilities Develop SOPs and maintain processes for...Local area$85k - $110k
...is looking to hire a senior quality engineer to join their team. This Sr... ...~5-8 years of experience in ISO/FDA medical manufacturing environment... ...experience with Class II or Class III medical device contract manufacturing... ...and encourage strong QMS (Quality Management System),...Contract work- ...talented and self-driven Quality Engineer to ensure all products,... ...management activities (ISO 14971), including FMEA and... ...Management System (QMS) in compliance with 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.... ...with working knowledge of FDA QSR, ISO 13485, and ISO...Contract workRemote work
$80k - $103k
...possibilities. For nearly 50 years, we’ve been engineering cutting-edge fluid connection... ...career growth? As our next Supplier Quality Engineer, you’ll be at the forefront... ...industry experience * Exposure to ISO: 9001 2015 and 13485 2016 * Experience working with data...Full timeTemporary workWork experience placementInternshipFlexible hours- Pharmavise Corporation in Maple Grove, MN is seeking a Design Quality Engineer III to develop and maintain quality engineering methodologies for medical devices. The ideal candidate will have at least 3 years of experience in the Medical Device industry, a functional understanding...
- ...prioritizing, communicating, and resolving quality issues. Support the verification,... ...deliverables. Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field... ...use of Quality tools/methodologies ISO 13485, ISO 14971 and Quality System Regulations...Full time
$75k - $123k
Global Supplier-Quality Engineer Date: Apr 2, 2026 Location: Maple Grove, MN, US Summary The Supplier Quality Engineer (SQE) is responsible for ensuring that suppliers of electronic components, PCB assemblies, mechanical parts, and outsourced manufacturing meet the stringent...Contract workFor contractorsWork at office$58.2k
...in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions. About the role: The Quality Engineer I will collaborate with Quality Management to recommend, design, and implement functional process improvements across the manufacturing...Hourly payInternshipWork at officeWorldwideShift work$75k - $112k
...provides contract manufacturing of high-quality, tight-tolerance medical implants, components... ...of companies. Learn more at Quality Engineer Position Summary The Quality Engineer will... ...comply with the company Quality System, ISO, and medical device requirements Qualifications...Hourly payContract workTemporary workWork at officeLocal area$96k - $134.5k
...DESCRIPTION Job Title Quality Systems Engineer Job Description... ...Management Systems to meet FDA 21CFR820 (QMSR), ISO13485,... ...• Support the respective QMS architecture and processes.... ...include proficiency in of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good...Full timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week$61.3k - $122.7k
...with heart arrhythmias, or irregular heartbeats. Supplier Quality Enginee r II drives improvement and corrective action in the quality of... ...components for use in products. Provide input to Design Engineering on new component technology and assist in component...Full timeWork experience placement- ...feel like home. Join our team as a Quality Systems Engineer! This is a fixed hybrid role (onsite... ...improve our Quality Management System (QMS) as we grow our leadership in digital... ...the company’s QMS in alignment with ISO 9001, ISO 13485, AS9100, and internal procedures...Permanent employmentTemporary workWork experience placementWork at officeLocal areaImmediate startRemote workFlexible hours
- A global electronics manufacturer in Maple Grove, MN is seeking a Global Supplier-Quality Engineer responsible for ensuring that suppliers meet quality and regulatory standards. The ideal candidate will have a Bachelor's degree in engineering and experience in supplier...
$58.2k - $110.5k
A leading medical solutions firm in Maple Grove is seeking a Quality Engineer I to improve manufacturing processes and ensure regulatory compliance. The ideal candidate will work closely with cross-functional teams, leading investigations and quality projects. Applicants...
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