Quality Specialist

3 weeks ago

Moncton, Canada bioMérieux SA 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.

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