About this role
We’re hiring a Quality Assurance Medical Devices Specialist for our client, a Biopharmaceutical company, to join their team. This is a full time opportunity.
- Quality assurance activities for medical devices (and combination products)
- Develop and implement the Quality Management System (QMS) as per ISO 13485, FDA 21 CFR 820 and jurisdiction-specific regulatory requirements as appropriate to fulfill the basic requirements that manufacturers of medical devices distributed in the U.S., Europe and Canada must comply with.
- Assist to establish and realize departmental strategies to support Company objectives.
- Assist the RAQC team to correspond with regulatory agencies, auditing organizations, and notified bodies and respond to quality deficiencies; and provide support to the regulatory team to produce/update regulatory related documentation.
- Support the design and development activities with an emphasis on risk management processes applied throughout the medical device lifecycle (as per ISO 14971) to ensure compliance to regulations and requirements.
- Review and approve product design change orders and deviations, considering quality, regulatory and compliance impacts.
- Prepare the company for audits (FDA, EU MDR, MDSAP) and/or regulatory inspections in collaboration with other functions.
- Ensure post-market regulatory requirements are met (e.g. medical device reporting, complaint investigations, customer surveys etc).
- Support marketing, clinical, and manufacturing departments (including that of CMOs) to ensure compliance to regulatory and quality requirements.
- Support the team as the company’s Medical Devices quality representative by promoting awareness of regulatory and quality requirements, ensuring processes required for QMS are documented, and assist the Associate Director QA to report to management on the effectiveness of QMS and any need for improvement.
- Provide continual training on QMS and regulatory requirements for medical devices to ensure organization-wide compliance.
- Stay informed of regulatory procedures, guidance documents, standards, and changes in regulatory and quality environment for medical devices and combination products.
- Review and approve documentation part of the Device Master Record (DMR) and maintain the documentation.
- Review Device History Records (DHR) for the release of the medical devices and maintain documentation of the device throughout its lifecycle.
- Participate in qualifying CMOs and suppliers required for the medical devices.
- Act as a Subject Matter Expert during audits by regulatory agencies and notified body.
- Review product stability studies and ensure compliance to design specifications.
- Review and negotiate quality agreements with suppliers as required.
- Review and investigate quality complaints implement corrective/preventative actions and notify management of trends.
- Assess customer satisfaction and evaluate trends.
- Organize and perform internal audits to ensure continuous compliance to regulations.
- Perform Annual Product Quality Review annually to determine any risks associated with the design, specifications and manufacturing processes of the device.
- Support other projects and activities as required.
- Bachelor’s degree or equivalent in Engineering, Science, or related scientific discipline.
- 3-5 years’ experience in quality assurance within the pharmaceutical industry, with sterile injectable products, pharmaceutical and /or biological products, and specifically with medical devices.
- Minimum 3 years medical devices quality assurance experience; and minimum 3 years in regulatory affairs ideally in medical devices is an asset.
- Advanced knowledge of US, EU and Canadian regulations and guidelines for medical devices.
- Experience developing and implementing a QMS system in accordance with applicable standards (including ISO13485, ISO 14971).
- Ability to identify quality compliance risks and escalate when necessary.
- Experience performing and hosting audits and inspections.
- Experience with developing procedures and quality system for medical devices.
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Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
- Resume or up-to-date LinkedIn / Xing profile
Any questions remaining?
Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto
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