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- ...professional attitude, and strong customer service skills ~ Knowledge of one or more quality systems: i.e., Malcolm Baldridge, ISO 9000, Lean, Kaizen, Army Corps of Engineers, Mortenson’s Quality System, continuous improvement, value streams, etc. ~ Experience...SuggestedH1bWork at officeWork visaFlexible hours
$150k - $165k
...proprietary RF) for data exchange between implantable devices and mobile apps. ~ Ensure adherence to medical device standards such as ISO 13485, IEC 62304, and FDA regulations throughout the software lifecycle. ~ Optimize software for performance, reliability, and...SuggestedFull time$30 - $40 per hour
...metrology equipment (CMM programming, etc.) Understanding of metrology principles and measurement techniques Working familiarity with ISO 9001 standards and Quality Management Systems (QMS). Excellent verbal and written communication skills. Proficiency in...SuggestedWork at office$82.45k - $139.15k
...pricing trends. Decipher trends, anomalies, and patterns in complex datasets. Research and monitor legislative, regulatory, and ISO/RTO-level developments affecting market design and energy pricing. Sustain comprehensive knowledge of regulatory markets while...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workFlexible hoursAfternoon shiftEarly shift- ...Analysis (RCA) & Problem Solving Hands-on experience with: FMEA Control Plans Quality Standards Knowledge: ISO 9001 TS 16949 / IATF 16949 External Lead Auditor certification (preferred) TS 9614 exposure preferred Ability to...SuggestedContract workRemote work
$150k - $165k
...mechanical subsystems and support closed-loop therapies. Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, and IEC 60601 series. Mentor and provide technical guidance to junior mechanical engineers; lead design reviews...SuggestedFull time$30.93 per hour
...analysis for defects and collaborate with teams to implement effective solutions. Support the Quality Assurance team in compliance with ISO 9001 standards. Participate in training sessions to enhance knowledge of quality assurance processes and products. Requirements...SuggestedHourly payFull timeWork at officeImmediate startShift workAfternoon shift$86.6k
...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 areaWorldwideRelocationShift work3 days per week- ...RFIs and grounding responses in engineering detail. ~ Familiarity with security and compliance frameworks such as HITRUST CSF, SOC 2, ISO 27001, or CSA STAR. ~ Experience creating or maintaining architectural diagrams and technical documentation. ~ Relevant...SuggestedHourly payContract workTemporary workFor contractorsImmediate startRemote workFlexible hours
- ...Certified Software Quality Engineers (CSQE) or equivalent certification. · Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA). · Experience with Software Reliability Engineering...SuggestedContract work
- ...Azure AD, Okta, Ping) Define scalable, multi-tenant IAM architectures for MSSP delivery. Ensure compliance with NIST, GDPR, ISO 27001, and Zero Trust principles. Collaboration & Innovation Work with delivery, product, and security ops teams to...SuggestedContract workRemote work
$130k - $160k
...transmission between active implantable devices and external interfaces. Ensure compliance with medical device standards, such as ISO 13485, IEC 62304, and FDA regulations, throughout the development lifecycle. Optimize firmware for low-power operation to extend the...SuggestedFull timeWork at office$150k - $180k
...activities for Enterra Medical products Achieve regulatory deliverables within project timelines and milestones with relevant FDA, EU, ISO and other regulatory requirements and standards Responsible for pre-market activities and post-market regulatory affairs...SuggestedFull timeWorldwide$86.6k
...design controls and risk management experience required. Understanding of US and International regulations including 21 CFR, 820, and ISO 13485 is required, as well as the Medical Device Directive, EUMDR, and EN ISO 14971. Preferred qualifications: Strong...SuggestedHourly payWork at officeWorldwideRelocation packageShift work3 days per week- ..., and the creation of educational materials. Maintain up-to-date knowledge of relevant industry standards (e.g., CLSI, USP, AOAC, ISO) and Client’ procedures and product offerings. Serve as a liaison between customers, distributors, and cross-functional teams....SuggestedMonday to Friday
$15,360 per week
...create lasting memories in this welcoming community. Prime Physicians is a physician-led, The Joint Commission (TJC) Accredited, ISO 9001 certified and CMMI Level 3 appraised organization. Our commitment extends beyond traditional consulting and management services,...Contract workLocal areaAfternoon shiftPrime Physicians
Minnesota7 hours ago$65k - $90k
...communicate through Teams, email, and phone. Provide intermittent on-call availability for emergency project needs. Support ISO 9001 efforts, internal audits, risk assessments, and corrective actions as needed. Perform other duties as assigned....Permanent employmentContract workInternshipWork at officeDahl Consulting
Minnesota3 days ago$43.13k
...on activities, and recommend actionable improvements when necessary. Ensure warehouse operations comply with safety protocols and ISO 13485:2016 guidelines. Maintain cleanliness and organization of the warehouse premises. Oversee maintenance of warehouse hardware...Part timeWork at officeFlexible hoursShift workMurata Americas
Minnesota2 days ago- ...touch probe, etc.) Ability to assist with designing/developing quality gauging to improve efficiencies Understands and adheres to ISO 9001 Able to read and understand all drawing criteria, GD&T, notes and tolerances. Experience with set-up of CMM or Romer Arm...Permanent employmentFull timeShift workWeekend work
Spacex
Swift County, MN7 hours ago $14.35 - $28.75 per hour
...when in training and then with moderate supervision once competent. Basic computer skill knowledge Working knowledge of GMP and ISO Standards preferred Ability to interpret and understand production documents and drawings to complete tasks Apply Now ( ~...Hourly payFull timePart time- ...supplier agreements, contracts, and logistics arrangements · Strong understanding of medical device manufacturing standards (GMP, ISO 13485, 21 CFR 820, EU MDR) preferred. · Experience in supplier risk management, escalation handling, and performance tracking required...Full timeContract workLocal areaFlexible hours
- ...ensure database updates and stakeholder communication. Stay current with industry and regulatory standards, including FDA guidance, ISO/IEC 81001-5-1, and AAMI TIR57/TIR97, and apply them to daily practices. Act as a subject matter expert, providing deep technical...Hourly payFull timeWork at officeLocal areaWorldwideRelocation packageShift work3 days per week
$90k - $110k
...Experience selling to Medical Device Manufacturers and/or Pharmaceutical companies Experience in a regulated/complaint industry (ISO, GAMP, FDA) is an asset. Compensation Base Salary Range: $90,000 - $110,000 In addition to base salary, this role is eligible...Full timeFlexible hours$80k - $95k
...tools and working as part of a cross-functional team. Lead changes in production, ensuring compliance with customer agreements, ISO standards, and internal requirements. Prepare, submit, and follow change requests (SCR) with customers. Assist production...Permanent employment$75k - $100k
...Experience with CNC Swiss and CNC milling. Knowledge of fixture design and Lean Six Sigma methodologies. Understanding of ISO standards. Additional Skills & Qualifications Bachelor's degree in Engineering, or an associate degree with 4 years of...Permanent employmentTemporary workFlexible hours$70k - $92k
...fixturing and tooling for complex parts. LEAN / Six Sigma training and demonstrated application. Experience working within an ISO environment. Work Environment This position is based at our facility in Big Lake, MN, where you will support the...Permanent employmentTemporary workFlexible hoursDay shift$100k - $115k
...Develop, implement, and maintain elements of the Quality Management System (QMS) to ensure ongoing compliance with FDA regulations, ISO 13485, and other applicable standards. New Product Development & Design Control : Collaborate with R&D, engineering, and cross-functional...Full timeMonday to FridayFlexible hours$61.3k - $122.7k
...Experience 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...Local areaWorldwideShift workDay shift$72k - $147k
...implementing a formal Safety Management System. Experience overseeing or implementing formal Hazard Prevention and Control Systems. ISO 14001 and 45001 occupational health and safety management system and environmental management system experience. Your Compensation...Flexible hours- ...maintain, and monitor processes and procedures ensuring high quality of the area product/service, efficient operation, and compliance with ISO 9001 requirements and corporate policies. Assures the product of service of the assigned area meets all applicable quality...Full timeContract workTemporary workLocal area
