Current jobs related to Senior Medical Devices Auditor - Mississauga, Ontario - SGS
-
Medical Device Quality Assurance Auditor
4 weeks ago
Mississauga, Ontario, Canada Intertek Full timeAbout Intertek Intertek is a global leader in quality assurance and testing, dedicated to exceeding customer expectations and fostering a culture of total quality assurance. We strive to make the world a better, safer, and more sustainable place for everyone. Role: Medical Device Quality Assurance Auditor As a Medical Device Quality Assurance Auditor, you...
-
Medical Device Compliance Auditor
1 month ago
Mississauga, Ontario, Canada Intertek Full timePosition: Medical Device Compliance AuditorCompany: IntertekThe Medical Device Compliance Auditor is essential in evaluating client management frameworks within the medical device sector. Key responsibilities encompass assessing client systems for adherence to industry regulations and standards, aiding clients throughout the certification journey, compiling...
-
Medical Device Compliance Auditor
1 month ago
Mississauga, Ontario, Canada Intertek Full timePosition: Medical Device Compliance AuditorCompany: IntertekThe Medical Device Compliance Auditor is essential in evaluating client management frameworks within the medical device sector. Key responsibilities encompass assessing client systems for adherence to industry regulations and standards, aiding clients through certification procedures, compiling...
-
Medical Device Compliance Auditor
1 month ago
Mississauga, Ontario, Canada Intertek Full timePosition: Medical Device Compliance AuditorOrganization: IntertekThe Medical Device Compliance Auditor is essential in evaluating client management frameworks within the medical device sector. Key responsibilities encompass assessing client systems for adherence to industry regulations and standards, guiding clients through certification procedures, drafting...
-
Auditor - Medical Devices (Part Time) Ontario
2 weeks ago
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly skilled and experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key...
-
Auditor - Medical Devices (Part Time) Ontario
2 weeks ago
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly skilled and experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key...
-
Senior Medical Device Development Engineer
2 weeks ago
Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full timeAbout the Role:We are seeking a highly skilled and experienced Senior Medical Device Development Engineer to join our team at Baylis Medical Technologies Inc. As a key member of our research and development team, you will play a critical role in the conception and development of novel medical devices for minimally invasive procedures.Key...
-
Senior Medical Device Development Engineer
2 weeks ago
Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full timeAbout the Role:We are seeking a highly skilled and experienced Senior Medical Device Development Engineer to join our team at Baylis Medical Technologies Inc. As a key member of our research and development team, you will play a critical role in the conception and development of novel medical devices for minimally invasive procedures.Key...
-
Medical Device Auditor
2 weeks ago
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key ResponsibilitiesAudit...
-
Medical Device Auditor
3 weeks ago
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key ResponsibilitiesAudit...
-
Auditor - Medical Devices (Part Time) Ontario
2 weeks ago
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key ResponsibilitiesAudit...
-
Auditor - Medical Devices (Part Time) Ontario
3 weeks ago
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key ResponsibilitiesAudit...
-
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly skilled Auditor - Medical Devices to join our team in Ontario. As a key member of our Business Assurance team, you will be responsible for leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key ResponsibilitiesAudit client...
-
Mississauga, Ontario, Canada Intertek Full timeJob SummaryWe are seeking a highly skilled Auditor - Medical Devices to join our team in Ontario. As a key member of our Business Assurance team, you will be responsible for leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.Key ResponsibilitiesAudit client...
-
Senior R&D Engineer
2 weeks ago
Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full timeAbout the RoleWe are seeking a highly skilled Senior R&D Engineer to join our team at Baylis Medical Technologies Inc. in a pivotal role that will drive the development and maintenance of our innovative medical devices.Key ResponsibilitiesCollaborate with cross-functional teams to integrate into every stage of product development, from conceptualization to...
-
Senior R&D Engineer
2 weeks ago
Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full timeAbout the RoleWe are seeking a highly skilled Senior R&D Engineer to join our team at Baylis Medical Technologies Inc. in a pivotal role that will drive the development and maintenance of our innovative medical devices.Key ResponsibilitiesCollaborate with cross-functional teams to integrate into every stage of product development, from conceptualization to...
-
Senior Process Engineer
2 weeks ago
Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full timeJob SummaryWe are seeking a highly skilled Senior Process Engineer to join our team at Baylis Medical Technologies Inc. As a key member of our process development team, you will play a pivotal role in designing, developing, and optimizing manufacturing processes for our medical devices.Key ResponsibilitiesProcess Development: Lead the development of new...
-
Senior Process Engineer
2 weeks ago
Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full timeJob SummaryWe are seeking a highly skilled Senior Process Engineer to join our team at Baylis Medical Technologies Inc. As a key member of our process development team, you will play a pivotal role in designing, developing, and optimizing manufacturing processes for our medical devices.Key ResponsibilitiesProcess Development: Lead the development of new...
-
Senior Medical Device Engineer
4 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout Boston Scientific Boston Scientific is a global leader in medical science, dedicated to improving patient lives through innovative medical solutions. We are committed to diversity, innovation, and high performance, and we value global collaboration and a winning spirit. Job Summary We are seeking a highly motivated and experienced Senior Medical...
-
Senior Medical Device Engineer
2 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleThe Senior Medical Device Engineer will join our Access Solutions Site to lead the development of our next generation steerable sheath for the franchise. This role will develop new technology, products, equipment, and processes with minimal supervision.Key ResponsibilitiesSupport complex cutting-edge medical device systems through prototyping,...
Senior Medical Devices Auditor
3 months ago
Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Job Description
This position performs third party audits in Canada and the US and technical information review per SGS Certification procedures and the requirements of ISO 9001, ISO 13485, ISO 13485 under CMDCAS, MDD, MDSAP, IVDR, UKCA and/or JPAL.
- Lead Auditors have authority for the control and performance of auditing activities including planning and the control of other members of audit teams.
- Lead a team of auditors in performing medical device audits, in conformance with the SGS Global/Local procedures
- This position is responsible to collect and analyze sufficient information to provide a recommendation for certification.
- Access and review North American clients' medical devices quality systems and technical information to the requirements of ISO 9001, ISO 13485 and other regulatory requirements for access into Canada, EU, and Japan. Review technical dossiers to the requirements of 93/42/EEC (MDD) and/or 98/79/EC (IVDD).
- Decide upon evidence gained during audits whether or not manufacturers are in compliance with all relevant standards / regulations, and if registration should be recommended or allowed to continue.
- Provide technical advice to marketing and sales functions, as required. Utilize and maintain professional communication and presentation skills while meeting with clients.
- Conduct public presentations / seminars on specific standards, where required.
- Education: Minimum Bachelor's Degree in Science or Engineering, or equivalent
- 10 years' experience in Medical Devices Manufacturing/Industry with 3 years minimum experiences in quality or regulatory related functions.
- Minimum 5 years of experience auditing for ISO 13485, MDSAP, MDD, IVD, IVDR, UKCA,and MDR standards.
- Satisfactory completion of an RAB/QSA or IRCA approved training course in Quality auditing. The course(s) must include an examination, which must be passed to evidence satisfactory completion.
- Registered (IRCA and/or RAB/QSA) Quality Lead Auditor is a MUST
- Strong background in either design engineering or research and development
- Global Regulatory Affairs background, including MDD / IVDD.
- FDA 510(k) experience
- Experience in radiation, neurological, soft tissue implant, absorbable products, orthopedic, active therapeutic/diagnostic supplying energy, active administration, animal tissue, and/or combination product devices
- Have competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.
- Broad knowledge of engineering and technical applications used in the development of medical devices.
- Ability to travel (80% 100%) to the US,including a valid driver's license.
- Extended hours and shift work may be required from time to time.
SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process.
We are prepared to receive applications from candidates not based in Canada and can support visa and relocation fees.
#SGSSJ
