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- ...engineers on setup, calibration, rework, quality testing, and experiments, while ensuring compliance with all safety rules, QSR, and ISO standards. Requirements / Must Have Ability to work within a team and independently in a fast-paced environment. Ability to work with...SuggestedWork experience placementShift work
- ...process Work with engineers in conducting experiments Observe and comply with all safety rules and regulations, including QSR and ISO Standards Participate in the Material Review Board (MRB) decision process Identify and implement corrective actions for manufacturing...SuggestedWork experience placementShift workAfternoon shift
- ...procedures. Conduct experiments under the direction of engineers. Comply with all safety rules and regulations, including QSR and ISO standards. Participate in Material Review Board (MRB) activities. Identify and implement corrective actions for manufacturing-...SuggestedShift workAfternoon shift
- ...accordance with MEDDEV 2.7/1 Rev 4 and MDR Submissions. Working knowledge of medical device clinical regulations, standards and guidelines (ISO, MEDDEV, MDR, IVDR, FDA CFR) and experience conducting focused literature searches on PubMed, Embase, Google Scholar, or other...SuggestedFlexible hoursShift work
$19.15 - $38.35 per hour
...validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning. Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements. Experience with optical measurement equipment, hand tools, gages, pressure...Suggested$75.3k - $150.7k
...preferred 3+ years in a regulated manufacturing environment (medical device or pharmaceutical preferred). Knowledge of: FDA regulations, ISO 13485, and GMP. Lean Manufacturing principles and tools. Cleanroom operations and contamination control. What We Offer At Abbott,...SuggestedWork at officeLocal areaWorldwideDay shift$86.6k
...Quality Systems or Quality Assurance role In‑depth understanding of Quality Management System requirements, including 21 CFR Part 820 and ISO 13485 Conceptual, practical, and functional knowledge of quality principles, with a general understanding of related job functions...SuggestedHourly payWork at officeLocal areaWorldwideShift work3 days per week- ...on sales or purchase orders; inventory levels; and product issues, causes, and resolutions. Quality: Oversee the implementation of ISO certification for specific criteria of product lines. Manage the documentation, revision, and control of product specifications, two-...SuggestedWork at officeLocal areaOverseasMonday to FridayNight shift
$60k - $120k
...experience Minimum 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 Solid communication and interpersonal skills. Project management and leadership skills, including the...SuggestedFor contractorsWork experience placement$66.7k - $133.3k
...capture, and reporting capabilities. Support validation activities for MES and ancillary MES equipment and ensure adherence to FDA and ISO standards. Process Optimization: Analyze current manufacturing processes and identify opportunities for digitalization and...SuggestedLocal areaWorldwide$82.6k
...understanding of design controls and risk management within the medical device industry ~ Fundamental understanding of the Quality System per ISO 13485 or 21 CFR 820 Preferred qualifications: Biomedical or anatomical understanding of urological systems Strong...SuggestedHourly payWork experience placementWorldwideRelocationRelocation packageShift work- ...cards) to ensure timely availability and compliance with protocol requirements. Maintain up‑to‑date knowledge of regulatory standards (ISO‑14155, ICH GCP, FDA) and ensure all activities adhere to applicable guidelines and SOPs. Manage the coordination and administration...SuggestedFull time
- ...Works with engineers in conducting experiments. Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards. Participates in the Material Review Board (MRB) decision process Identifies and implements corrective actions for manufacturing...SuggestedWork experience placementLocal areaShift workAfternoon shift
- ...research or equivalent experience gained with a CRO, pharmaceutical, or medical device company. ~ Knowledge of ICH/GCP Guidelines, ISO 14155, and FDA and EU MDR, including a basic understanding of regulatory requirements in other countries. ~ Ability to work with minimum...SuggestedFull timeLocal areaFlexible hours
$130k - $170k
...Mechanical, Biomedical Engineering, or related discipline. Master’s degree preferred. Knowledge of 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971, ISO 10993, and IEC 62366. 3‑D solid modeling experience (e.g., SolidWorks or related software). Hands‑on...Suggested- ...Science in Mechanical, Biomedical Engineering, or related discipline. Master’s degree preferred. 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366. 3D solid modelling (e.g. SolidWorks or related software). Hands-on experience with machining...
$48k - $80k
...assigned by departmental management. To succeed in this role, you’ll need: 2-4 years of experience working in a quality control role with ISO and GMP systems requirements with a high school education (an equivalent combination of experience and education may be considered)...$100k - $120k
...Aerospace Auditor certification through an approved scheme (AA, AEA, or equivalent with OASIS recognition) is necessary. Strong knowledge of ISO 9001, AS9100, AS9120, and related management system requirements is essential. Excellent communication skills in English, both...Permanent employmentFull timeLocal areaRemote work- ...Quality Manager will be responsible for developing, maintaining and improving software quality design processes, ensuring compliance with ISO 13485, FDA QSR (21 CFR Part 820), ISO 14971 and applicable SaMD regulations and guidance. This role involves supporting development...Full time
- ...value chain. + Maintain a transparent multi‑horizon roadmap (6/12/36 months) that sequences business outcomes and dependencies (e.g., ISO 20022 readiness, TMIS→MAX+ migrations, Payments Connect (Payabli), Connected Deposits/Qolo, Integrated Receivables/Versapay). +...Work at officeRemote workWork from homeFlexible hours
- ...Quality Auditor ISO 9001 The Quality Assessments Division of Smithers seeks full-time Auditors to join our ISO Sector team. If you want to be a part of our mission to provide our clients with accurate data, on-time with high-touch, we'd love to have you on board....Full timeTemporary workWork experience placementFlexible hours
- ...ISO 13485 Lead Auditor RQM+ is the MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic...Contract work
$17.2 - $31.9 per hour
A leading electrical solutions provider is seeking a Quality Inspector to perform product inspections and ensure compliance with quality standards. The ideal candidate has a high school diploma and 1 year of experience in quality processes. Skills in precision measuring...Hourly pay$70k - $95k
A technology manufacturing company in Maple Grove, MN seeks a Quality Engineer responsible for ensuring product quality through Quality Management, leading audits, and continuous improvement. Candidates should have 3-5 years of relevant experience and a Bachelor's degree...- A leading manufacturing company in Minnesota is seeking a Certification Technician to compile and distribute product certifications for Turbine and Energy products. This role requires proficiency in certifications and quality assurance, along with required skills like MS...
- A leading medical supply company in Ham Lake, MN is seeking a Buyer/Planner to manage purchasing and inventory while ensuring compliance with regulatory standards. Candidates should have strong analytical skills, experience in supply chain operations, and familiarity with...
- ISO 13485: 2016 Freelance Auditor - US Midwest 1 day ago Be among the first 25 applicants Medpoint is seeking certified ISO 13485: 2016l auditors to conduct contract supplier audits. Successful candidates will meet the following requirements: Experience auditing supply...Full timeContract workFor contractorsFreelance
$70k - $95k
A manufacturing firm specializing in quality assurance in Eagan, MN is seeking a Quality Assurance Manager to oversee QA operations and ensure compliance with all regulations. The ideal candidate should have a Bachelor's degree in relevant fields and 3+ years of experience...Full time- ...in machining processes. You'll work in a fast-paced environment, collaborating with a team to meet production goals while adhering to ISO 9001:2008 standards. This position offers the chance to develop your skills in a supportive setting, where your contributions will be...
- ...Chinese, with a strong understanding of contracts in regulated environments such as Medical Devices or life sciences. Familiarity with ISO 9001 and ISO 13485 certification requirements is essential. This role offers an exciting opportunity to contribute to quality...