Career Opportunity in Montreal:
My client is a dynamic, fast-paced, global organization in the medical device industry that truly believe in not only their revolutionary technology but in the growth and development of their employees.
We are currently searching for a: Quality Engineer
There are key components to this role with focus on - Product Development:
· Provide quality, regulatory and standards expertise to engineering teams to meet design requirements.
· Execute the risk management plan and work with the engineering team to identify, document and control risks as per ISO 14971 & IEC 62304.
· Participate in Design Reviews and ensure that the product is developed in accordance with regulatory requirements, customer requirements and identified risks.
· Participate in the review of product requirements.
· Ensure products are evaluated and tested for compliance with all applicable codes and standards (CE, CSA, FCC, ISO, UL, etc).
· Ensure verification and validation (V&V) activities are in accordance with design control procedures. Review and approve V&V deliverable and ensure that the product meets the applicable requirements.
· Participate in the evaluation and resolution of deviations and anomalies identified by the V&V team.
· Participate in the definition of the product transfer requirements in production.
· Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
· Contribute to the product development plan in collaboration with the Program Directors and Product Owners in order to resolve quality issues.
as well as Product sustainability:
· Ensure that customer requirements and regulatory compliance of the product are maintained through evaluation of design and regulatory changes.
· Assess risks throughout the product life cycle and maintain the risk management plan.
· Feedback and complaint handling (Perform a complaint data and trend analysis; Initiate and lead complaint investigations; Collect and present the DATA in the periodic reviews).
· Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
· Update the risk file following the analysis of complaints.
· Communicate design changes to the Notified Body to maintain product certification.
· University degree in electrical/electronic, mechanical, electro-mechanical or software engineering;
· 3 -4 years experience in regulated industry (e.g. medical device, pharmaceutical, aerospace, automotive);
· Proficiency in French and English;
· Knowledge of design control requirements, including verification and validation (systems and software V&V), process validation, equipment qualification and risk management;
· Knowledge of quality management systems (e.g. ISO 9001, ISO 13485, ISO 14001);
· Excellent computer skills (MS Office suite, particularly Excel and Word; analytical software tools (e.g. MATLAB));
· Ability to analyze and synthesize;
· High level of interpersonal skills.
Job Types: Permanent, Full-time
Salary: From $85,000.00 per year
- Dental care
- RRSP match
- Vision care
- Work from home
My client is offering a hybrid work model for this role (home/office).
Work Location: In person