Remote Medical Device Auditor - Lead ISO 13485 & MDSAP
Intertek CEA
Boxborough, MA
- Remote job
Intertek is seeking an experienced Medical Device Auditor to lead and participate in 3rd party audits across multiple sites. The role requires extensive travel (3–5 nights per week) and living in the United States. You will assess management systems for ISO 13485 compliance, train junior auditors, and interface with clients throughout the certification process. Applicants should have a biology/technical degree, 4+ years in medical device auditing, and strong communication, documentation, and #J-18808-Ljbffr Intertek CEA
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Remote Medical Device Auditor - Lead ISO 13485 & MDSAP in Boxborough, MA vacancy
- ...Medical Device QA Auditor Join the GMED team today and work on the frontier... ...Location(s): Rockville, MD or Remote (Home office) Job... ..., our QA Auditors conduct ISO 13485/MDSAP audits and CE Marking activities... ...US subsidiary of GMED, a leading Certification Organization...Remote workMedical deviceFull timeContract workTemporary workWork experience placementWork from homeWorldwideHome officeFlexible hours
GMED NA
United States4 days ago $126k - $138k
...looking for an experienced QMS Internal Auditor who will play a crucial role in ensuring... ...This position requires strong expertise in ISO 13485 and direct internal auditing experience... ...benefits including 401(k) matching, medical, dental, and vision insurance. #J-18808-...Medical device$109.25k - $149.5k
...standards of care.SUMMARYThe Lead Auditor, Quality Compliance... ...portfolio of leading medical devices. Ensure that the corporate... ...with recognized ISO, GMP, GDP, GCP, and GLP... ...the 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country requirements; personal...Medical deviceFull timeTemporary workWork experience placement- ...Quality Systems Specialist to ensure successful implementation of ISO 13485 compliant QMS policies and procedures. This role ensures... ...meet quality standards and customers' requirements for medical devices. Responsibilities include maintaining calibration, document control...Medical deviceDay shift
$92k - $138k
...FDA regulations, ISO standards, and... ...raw materials, medical devices,... ...manufacturing sites. Lead complex, critical... ...regulations, ISO13485, MDSAP, MDD/MDR and... ...training to junior auditors, divisional QA... ...with ISO 13485.- Experience applying... ...: REMOTE- IllinoisType:...Remote workMedical deviceMinimum wageRotational programFull timeContract workWork experience placementLocal areaWorldwide- ...ISO Lead Auditor, Remote, India At Prescient Security, we are on a mission to simplify security and compliance. Our core values are: ~ Bring Order to Chaos ~ Be Accountable & See it Through ~1000% With You ~ Support & Collaborate ~ Think Outside the...Remote workFlexible hours
Prescient Security
United States16 hours ago - ...assurance for the oil, gas & energy sector. Job Description ISO 27001 LEAD AUDITOR Kerndell is seeking an experienced ISO 27001 Lead Auditor to... ...lead Stage 1 (documentation review) and Stage 2 (on‑site or remote) audits against ISO 27001:2022 requirements. Develop audit plans...Remote work
Kerndell
Saint Paul, MN1 day ago - ...ISO 19443 Lead Auditor Location: Hartford, CT, US Job Type: Full-Time Work Mode: Remote Job Level: Professional Job ID: 13822 Company: HSB Employment Type: Regular Area of Expertise: Engineering & Inspection Description: Location: Flexible...Remote workFull timeFlexible hours
Hartford Steam Boiler Inspection and Insurance Company
Hartford, CT2 days ago $80k - $110k
...age, ancestry, color, family or medical care leave, gender identity or expression... ...Title : Quality Engineer, Site Lead Location : Chicago, IL (onsite)... ...role has primary ownership of ISO 9001 compliance and supports ISO 13485 medical device silicone operations as needed. It...Medical devicePermanent employmentWork at office- DQS South Africa (Pty) Ltd. is seeking a part-time Contract Lead Auditor for ISO 9001:2015 in Schaumburg, Illinois. The successful candidate will perform assessments and certifications, visiting client locations to provide audit services. A 4-Year College Degree and at...Remote jobDaily paidContract workPart time
- DQS South Africa (Pty) Ltd. is seeking a qualified Contract EHS Lead Auditor in Schaumburg, Illinois. This part-time role requires knowledge of ISO 14001 and 45001 standards with extensive travel required within the US and Canada. The ideal candidate will possess strong...Remote jobContract workPart time
- ...3rd Party Qualified Medical Device Auditors - Full-time - Travel... ...experienced Notified Body and MDSAP Auditing Organization... ...business by leading and/or participating... ...per week. This is a remote position; however, applicants... ..., specifically ISO 13485, regulatory requirements...Remote workMedical deviceFull timeWork experience placementNight shift
- Vonco Products, LLC is seeking a hands-on Quality Manager to lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. The role partners with Operations, Engineering, Supply Chain...Medical device
- Vonco Products, LLC is seeking a Quality Manager to lead the ISO 13485 quality system and ensure compliance with regulatory and customer requirements in a medical device environment. This role partners with Operations, Engineering, Supply Chain, and Customer Service to...Medical device
- American Society for Quality in Kentucky seeks a hands-on Quality Manager to lead the ISO 13485 QMS for a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain, and Customer Service to ensure regulatory compliance, drive...Medical device
- ...Products seeks a Quality Systems Manager to maintain the Quality Management System and oversee QA/QC activities in support of ISO 13485 and medical device regulatory requirements. This hands-on leadership role involves managing quality system processes, QA/QC activities, and...Medical device
$85k
...Corporate Quality Internal Auditor will perform Global... ...manage audits as lead auditor at various... ...U.S. and Worldwide medical device regulations. Evidence... ...training to QSmR, ISO 13485:2016, EU MDR, MDSAP and ISO 9001:2015... ...8%. #LI-YA2 #LI-Remote About us With...Remote workMedical deviceTemporary workWorldwideFlexible hoursGetinge
Nashua, NH29 days ago- ...maintenance of the quality management system. You will specialize in ISO 13485 and CFR 820.30, define document structures, oversee... ...continuous improvement and ensure regulatory compliance across medical device programs. You will provide strong quality focus while...Medical deviceWorldwide
- DQS South Africa (Pty) Ltd. is seeking a Medical Device Lead Auditor for an immediate contract opportunity. The position is home-based with extensive travel required. Candidates should have a Bachelor's degree in life sciences or engineering and at least four years of experience...Remote jobMedical deviceContract workImmediate startWork from home
$40 - $43 per hour
...Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US... ...Auditing experience within the medical device or pharmaceutical industry ~ Extensive experience leading supplier/vendor audits... ...Parts 210, 211, and 803), ISO 13485, and Quality Management Systems...Remote workMedical deviceContract workTemporary workMedical Devices and Supplies
United States2 days ago$100k - $115k
Auditor, Lead Job DescriptionThe Auditor, Lead will plan, conduct, and... ...Program. This position is remote.What You Will Do:Attend any... ...AS9100. Authentication in ISO 9001, 14001 or 13485 will be acceptable with experience... ..., but are not limited to, medical insurance (PPO and HD),...Remote workWork at officeWork from homeFlexible hours- ...ensuring processes are established, implemented, and maintained. Responsibilities include leading audits, CAPA, ECO, and MRB activities, developing metrics, and coordinating risk assessments and validation programs under FDA QSR 820 and ISO 13485. #J-18808-Ljbffr ARCHMedical device
- Adecco is seeking a detail-oriented Quality Inspector to uphold ISO 13485 and FDA 21 CFR 820 standards for a medical device manufacturer. You will test and inspect products at multiple production stages to ensure quality and reliability, working closely with Production,...Medical device
$151k - $176k
...to protect humankind.*LEAD WITH HEART: Everyone leads... ...Supplier & Internal Auditor to support the Quality... ..., GLP, GCP, ICH, and ISO 13485 requirements and... ...pharmaceutical, biotechnology, or medical device industries.Essential... ...audits (on-site and remote) in support of...Remote workMedical device3 days per week- ...Lead Auditor This position is posted on a continuous basis and does not have a fixed application close date. Applications... ...conduct onsite audit, however many audits are done remotely Qualifications: Must have: ISO 9001:2015, ISO 14001:2015 and/or ISO 27001 Lead...Remote workFull timeFor contractorsWork experience placement
- ...Global Regulatory Affairs Lead Strivector Corp is a National... ...and compliance activities for medical device products. This role will... ...Management Systems including: ~ ISO 13485 ~21 CFR Part 820... ...Location: Covington, Georgia Remote / Hybrid: On-site (4 days per...Remote workMedical devicePermanent employmentFull timeFor contractorsRelocation
$120k - $150k
...CooperSurgicalCooperSurgical is a leading fertility and women’s... ...over 600 clinically relevant medical devices to healthcare providers, including... ...of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.Strong... ...audit programs (onsite, remote, desktop).Ensure effective management...Remote workMedical device- ...Workplace Flexibility: Remote For more... ..., by advancing medical technologies and elevating... ...Drives/leads root cause analysis... ...history file (DHF), device master record (DMR... .... 21CFR part 820, ISO 13485, ISO 14971). Working... ...of FDA QSR's, MDSAP, ISO 13485, Design...Remote workMedical deviceLocal areaWorldwide
Olympus Corporation of the Americas
Center Valley, PA20 days ago - ...Minnesota seeks a Quality Control Inspector to oversee inspection activities within the department for medical device manufacturing. The role emphasizes adherence to ISO 13485, GDP/GMP, and proper documentation of inspections on machined components using conventional layout...Medical device
- ...Your role DQS Inc. has an immediate opening for Aerospace Lead Auditors who have already achieved AEA or AIEA status. Positions are home... ...of principles and methods for management systems audits. ISO-9001 and AS9100 auditing with 3rd party experience is a must- MUST...Remote workContract workImmediate startWork from homeRelocation
DQS Inc
United States3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Medical Device Auditor - Lead ISO 13485 & MDSAP. Be the first to apply!
Related searches
- remote software sales Boxborough, MA
- on-site clinical research associate (traveling/remote) Boxborough, MA
- remote work Boxborough, MA
- part time remote tech Boxborough, MA
- remote design intern Boxborough, MA
- telecommute Boxborough, MA
- remote engineering internship Boxborough, MA
- remote Boxborough, MA
- companies hiring remote Boxborough, MA
- clinical data coordinator remote Boxborough, MA