You will like
Working in Mississauga, Greater Toronto Area - GTA for this entrepreneurial medical device firm with opportunity for growth, providing innovative medical products before, during & after Covid-19!
Members of this pioneering firm share a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals under the leadership of an active CEO who is 'going places!
You will like
The QA Specialist Medical Device job itself within a small, focused essential team conducting rewarding work related to life-saving devices.
You will be involved in the successful running of a Quality Management System, presently paper-based, covering all aspects of product quality and regulatory compliance (Health Canada and EU Medical Devices), non-conformities, ISO 13485, and any agency actions. Products are Class III Medical Devices. More specifically:
- Part of the team running the QMS.
- Ensuring that products meet quality requirements - Canada, EU (MDD), ISO.
- Help with all quality / regulatory audits, and inspections.
- CAPA, post-market surveillance, liaising with clients, operations, sales and marketing as necessary.
- Helping provide excellent business solutions for manufacturing and process improvement.
- Taking part in product production and release.
- Help with MDR/vigilance reporting, document control, microbiology, product release functions.
You will have
To be successful as the QA Specialist Medical Device you will have
- BS Biology, Biomedical Engineering, related.
- Experience running Quality Management Systems.
- Quality Management metrics.
- Experience with ISO 13485, audits, compliance.
- History working with Class III and or IV Medical Devices very helpful.
- Any certifications - e.g. ASQ / CQA / CBA or ISO 13485
You will get
As QA Specialist Medical Device, you will enjoy a highly competitive Salary $Negotiable + Benefits
You can apply
To QA Specialist Medical Device by pushing the button on this job posting (recommended), or by sending CV in confidence to email@example.com