Associate Consultant, Medical Device Quality

1 week ago

Toronto, Canada Klick Health Full time

Klick Consulting is seeking a passionate Associate Consultant with a focus on medical device quality management to join our growing team. Klick Consulting works alongside clients and their businesses to improve patient outcomes in healthcare by providing innovation and digital guidance to global clients operating across life sciences and consumer health, including pharmaceuticals, medical devices and biotech. Headquartered in Toronto, the team is made up of experts in a variety of disciplines, from business strategy to behavioral science to AI/ML

In this role, you'll leverage your expertise in medical device quality management systems (QMS) and your passion for improving patient outcomes to contribute to the success of our clients.

As an Associate Consultant with a specialization in QMS, you will play a dual role on the Klick Consulting team. You will play a pivotal role in supporting the insight generation process through research and analysis, including the collection of data from external research, client data, and expert interviews, while also being our in-house expert on QMS.

**Key Responsibilities**:

- Collaborate with clients' teams to coordinate Quality Management Systems (QMS) activities in alignment with ISO 13485, ISO 14971, and IEC 62304 standards
- Provide support in risk management activities according to ISO 14971, aiding in the identification and mitigation of potential risks
- Assist in the preparation for internal and external audits, ensuring compliance with regulatory standards
- Contribute to the enhancement of QMS through data-driven insights, incorporating customer feedback and audit results
- Support the integration of quality requirements into product development processes, working closely with cross-functional teams
- Communicate critical insights visually and verbally in client meetings, aiding in the decision-making process

**Qualifications**:

- Bachelor's degree in a relevant field such as Computer Science, Engineering, or Life Sciences
- Strong understanding of ISO 13485, ISO 14971, and IEC 62304 standards
- Interest in and familiarity with life sciences industries
- Excellent written and verbal communication skills
- Ability to collaborate effectively with diverse teams

LI-Hybrid #LI-ML1
- Klick is consciously creating a culture where everyone can thrive and grow in their careers. We believe that our best work comes from our diverse backgrounds, perspectives, and skills. We strongly encourage members of historically underrepresented communities to apply, including Black people, Indigenous peoples, and other people of colour, people with disabilities, people from gender and sexually diverse communities and people with intersectional identities._

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