Our Client in Ottawa, ON is currently looking for a Quality Assurance Manager to join their team. This is a permanent opportunity with a leading medical device manufacturer. Our client is offering a competitive compensation package based on level of experience.
Under the direction of the Senior Director Quality Assurance; the Quality Manager acts as a subject matter expert, providing guidance, mentoring and support of the quality management system while ensuring compliance with:
- FDA Quality System Regulation,
- Health Canada Medical Device Regulations and,
- Other international requirements as applicable, e.g. IVD Directive for CE Marking
Quality Assurance Manager Duties and Responsibilities:
- 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.
Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.
Quality Assurance Manager Job Demands:
- 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
- Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives
- Excellent high level oral & written communications skills enabling incumbent to act as a facilitator and/or educator with strong leadership skills
- Adaptable and willing to take on multiple new tasks and responsibilities
- Ability to understand a technically complex product
- Juggling and prioritizing multiple tasks within a dynamic work environment with tight timelines and limited resources
- Scaling of the quality system to suit a rapidly growing company
- Ensuring compliance while meeting business objectives
- Conflicting departmental priorities and obstacles to change
- Extended periods of sitting/computer use
Quality Assurance Manager Skills & Qualifications (Education and Experience):
- University Degree (preferably BSc, Engineering and/or formal training in QA) or a combination of education and experience
- 7 ¿ 10 years of industry experience with a minimum of 5 years or more experience in an ISO 13485 or cGMP manufacturing environment - preferably in medical devices/diagnostic devices
- 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
- High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc.
If you are interested in applying to the Quality Assurance Manager in Ottawa, ON, please click on Apply Now!