Quality Specialist

5 days ago

Montreal, Quebec, Canada bioMérieux Full time

Position Summary
Ensure regulatory compliance of bioMérieux Canada and compliance with applicable Quality Management System requirements (including ISO 9001 requirements).

Main Accountabilities

  • Ensure compliance with recall requirements of the Canadian Medical Devices Regulations (MDR SOR ∕98 – 242).
  • Ensure that Field Actions (FSCA, FCA, PSS, PRS) are implemented in a timely manner as per applicable regulatory and Corporate Requirements.
  • Assist in the execution and improvement of regulatory processes and interactions with regulatory agencies.
  • Monitor and maintain familiarity with applicable regulations and assist with the review and revision of related local procedures.
  • Act as a SAP key user
  • Participate in and support audits and inspections.
  • Participate in the management of the Quality Management System to ensure compliance with the applicable ISO 9001 standard and Corporate requirements.
  • Act as an internal auditor and assist our manufacturers with MDSAP related activities including audits.
  • Assist in the completion of local and Corporate QMS indicators and the definition and execution of action plans.
  • Support Commercial operations by responding to Quality related internal requests and Quality related customer requests (Quality Agreements and questionnaires, input for tenders, latex content requests, QC strain related requests) and act as a QA/RC resource person.

Studies And Experience

  • Requires a bachelor degree in Science, Biology or Quality. A Master Degree is an asset.
  • Requires knowledge of the Canadian Medical Devices Regulations (MDR SOR ∕98 – 242). Requires knowledge of the ISO 9001 standard and applicable Quality Management System requirements.
  • Requires knowledge of the ISO 9001 standard and applicable Quality Management System requirements
  • Requires 2+ years related experience in the Medical Devices Industry (IVD industry is an asset).

Skills And Qualifications

  • Strong computer skills including MicroSoft Office Package ( Word, Excel , PowerPoint, Outlook, Teams). Trackwise is an asset. SAP is an asset.
  • Rigor, reliability, respect of timelines
  • Good verbal, listening and writing communication skills.
  • Proven collaboration and time management skills.
  • Ability to work in an international environment.
  • Be able to demonstrate a strong adaptability and a great sense of autonomy.

  • Quality Specialist

    1 day ago

    Montreal, Quebec, Canada Desjardins Full time

    Desjardins's Wealth Management and Life and Health Insurance (WMLHI) IT Division is looking for a quality assurance specialist to join its quality assurance team. This team's mission is to help WMLHI IT teams become more autonomous, in terms of mastering practices and tools, as well as improve their development processes to speed up the delivery of quality...

  • Quality Control Specialist

    3 hours ago

    Montreal, Quebec, Canada Dorfin Full time

    As a Quality Control Specialist, you will be responsible for ensuring that products sourced from overseas manufacturers, primarily overseas, meet the Company's quality standards, regulatory requirements, and customer expectations. This role works closely with overseas suppliers, third-party inspection agencies, freight partners, and internal teams to prevent...

  • Quality & Export Specialist

    1 week ago

    Montreal, Quebec, Canada Näak Full time

    Are you passionate about trail running or any other endurance sport? Are you curious about the world of the food industry and eager to join a creative environment? If you're thirsty for adventure and want to help build the future of sports nutrition, then Näak is for youNäak is a fast-growing brand that provides high-performance, sustainable nutrition...

  • Quality Assurance Specialist

    1 week ago

    Montreal, Quebec, Canada PPT Full time

    Pacific Programming and Tech Inc., a computer software development firm based out of Montreal, QC, is currently looking for an experienced QA Specialist in the field of manual and automated testing for our Montreal-office location. We are currently offering a unique hybrid-work environment which includes a combined schedule of remote work-from-home days and...

  • Bilingual Audit Specialist

    3 days ago

    Montreal, Quebec, Canada Quality IT Resourcing Full time

    Bilingual Audit Specialist6 months contract with potential to convert to permWhat your typical day look like: Provide solutions to our clients on current business and financial conditions Assist in the planning and execution of the audits of financial statements Work in a fast growing and challenging environment with like-minded people who are...

  • Quality Assurance Specialist

    2 weeks ago

    Montreal, Quebec, Canada IMPORTER INC. Full time

    QUALITY ASSURANCE SPECIALISTIMPORTER INC. – Montréal, QCBased in Montreal, Quebec with offices in New York, NY and New Castle, DE, Laces Group Inc. ("Laces" or the "Company") is a leading designer, marketer, manufacturer and distributor of everyday bath and home products. The Company sells its products to over 500 customers and over 35,000 storefronts in...

  • Quality Assurance Specialist

    31 minutes ago

    Montreal, Quebec, Canada Harlow Payments Full time

    LocationMontreal, QC — Onsite (Near Peel Metro Station). Please note that we do not accept remote or hybrid candidates at this time.Who We AreAt Harlow Payments, we bring over 50 years of combined experience to the world of payment solutions. We're passionate about helping businesses streamline their payment processes, reduce costs, and achieve financial...

  • Quality Assurance Specialist

    7 days ago

    Montreal, Quebec, Canada Cirque du Soleil Full time

    Quality Assurance SpecialistInformation TechnologyPermanent positionWe were born from an eclectic troop of performers. Come live the experience of being yourself every day to create the extraordinary.OUR MISSIONSince 1984, Cirque du Soleil Entertainment Group has been focusing on ever more creative and magical work in order to constantly push the limits of...

  • Quality Assurance Specialist

    2 days ago

    Montreal, Quebec, Canada Mercuri Cuisine Inc Full time

    Company DescriptionMercuri Cuisine is a leader in airline and train catering solutions, as well as institutional and hospitality provisioning services. Specializing in onboard and airport lounge food services, the company is dedicated to innovating and enhancing the passenger experience. Mercuri Cuisine is committed to delivering restaurant-quality meals at...

  • Quality Assurance Specialist

    7 days ago

    Montreal, Quebec, Canada Cirque du Soleil Entertainment Group Full time

    Information TechnologyPermanent positionWe were born from an eclectic troop of performers. Come live the experience of being yourself every day to create the extraordinary.OUR MISSIONSince 1984, Cirque du Soleil Entertainment Group has been focusing on ever more creative and magical work in order to constantly push the limits of the imagination and surprise...