Roevin Engineering and Technology (A division of Adecco) is currently recruiting for a Quality Manager
located in our nation’s beautiful capital, Ottawa, Ontario. This opportunity will help lead the quality department of a well established and respected, medical device manufacturing company. Our ideal candidate has 5+ years of experience as a Quality Manager in an ISO 13485 conversant facility, together with an understanding of FDA Quality and applicable Health Canada regulations. You will be working for innovative company creating transformative products, within a dynamic work culture.
Responsibilities – Quality Manager
- Support design and new product introduction projects (software, hardware and sensor assays) as the QA representative by providing guidance on V&V requirements, DHF development and organization, design and phase reviews, risk management activities amongst others.
- Lead process owner for the Design Change and Design Control processes which includes training, mentoring and approving change packages, reviewing Design Verification and Validation activities and providing input on required activities.
- Lead Process Owner for Process Validation activities by approving verification, validation, IQ, OQ and PQ reports.
- Lead process owner for lot release (Review of data, decisions on product pass/fail)
- Lead large continuous improvement or lean manufacturing improvements for the facility to improve efficiency and compliance.
- Support external audits from regulatory bodies.
- Lead, coordinate and conduct quality system audits and supplier audits
- Develop training materials and conduct quality system training on key subsystems
- Facilitate and implement changes and improvements to the quality system to ensure the effective and efficient operation of the quality system.
- Develop quality plans and recommendations for improvement.
- Collect and analyze data from quality processes and generate regular reports.
- Maintain and improve quality system documentation, i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements as well as current company and industry practices
- Maintain quality systems that assure product conformance and customer satisfaction.
- Manage specific quality systems, i.e. corrective and preventive action system, non-conforming goods system, final product release, Complaints, Change Control, Documentation management and Supplier Quality initiatives etc.
- Proven experience conducting process and design validations.
Requirements - Quality Manager
- 5+ years’ industry experience with a minimum of
- 5+ years’ experience in an ISO 13485 or cGMP manufacturing environment - preferably in medical devices/diagnostic devices
- University Degree (preferably BSc, Engineering and/or formal training in QA) or a combination of education and experience
- ISO13485 and FDA Quality System Regulation (QSR) experience preferred
- ASQ certified designation Preferred: Certified Quality Auditor (CQA), Certified Quality Manager (CQM) or Certified Quality Engineer (CQE) preferred
- Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time
- Proven ability to manage projects, achieve timelines and stay within budget.
- Experience with personnel management and mentoring.
- Process orientated, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions
- Extended periods of sitting/computer use
If you are interested in this Quality Manager position in Toronto - apply by clicking apply now. If you would like to speak with me further about this opportunity, please call 1-877-272-4887 x 287 and ask for Craig Charnock or connect with my directly on LinkedIn at https://ca.linkedin.com/in/craigcharnock
Account Manager, Engineering and Manufacturing – Roevin
1-877-272-4887 x 287