Senior Quality Assurance Engineer Job in Ottawa, ON - Adecco
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Job Summary
Senior Quality Assurance Engineer
Location: Ottawa, ON Category: Manufacturing & Heavy Industry
Status: Direct Hire Reference: CA_EN_1_021956_11404794
Posted: November 15,2016 Salary: N/A

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Our Client in Ottawa is currently looking for a Senior Quality Assurance Engineer 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 supervision of the Quality Assurance Manager; the Senior Quality Assurance Engineer is responsible for acting as a Technical Expert supporting Operations and R&D by providing guidance and direction on activities necessary to comply with the quality system and with
- ISO13485,
- FDA Quality System Regulation,
- Health Canada Medical Device Regulations and,
- Other international requirements as applicable, e.g. IVD Directive for CE Marking

Senior Quality Assurance Engineer Duties and Responsibilities:
- Supports new product introduction initiatives as the Quality delegate by participating on project teams and providing independent technical review of designs and providing input into required Verification and Validation activities.
- Works with change initiators to support change initiatives by providing guidance on required verifications and validations. Approve change packages and associated verifications and validations.
- Performs the QA review and approval of Planned Deviations,
- Guides Quality Incident (non-conformance) and CAPA investigational activities ensuring thorough root cause analysis and appropriate corrective actions. Approve Quality Incidents (disposition product) and CAPAs, ensuring they are technically accurate, compliant to procedure and complete.
- Develops quality plans and recommendations for improvement
- Implements changes to the quality system ensuring continuous improvement to ensure the effective and efficient operation of the quality system
- Oversees key quality systems and maintain and improve quality system documentation, i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements.
- Maintains and supports quality systems that assure product conformance and customer satisfaction
- Collects and analyzes data from quality processes and generate reports.
- Develops training materials and conduct quality system training, as required.
- Supports internal and external audit processes by leading, coordinating and/or conducting quality system audits, as required.
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.

Senior Quality Assurance Engineer 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.
- 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
- Physical:
- Extended periods of sitting/computer use
- Ability to distinguish between colours

Senior Quality Assurance Engineer Skills & Qualifications (Education and Experience):
- University Degree (preferably BSc or Engineering) and/or an equivalent combination of education and technical experience
- 5 ¿ 10 years of industry experience in operations, R&D or QA within an ISO registered manufacturing environment
- ISO13485 and FDA Quality System Regulation (QSR) experience preferred
- ASQ certified designation: 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 apply to the Senior Quality Assurance Engineer in Ottawa, Please click on Apply Now!



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**Note: Accommodation will be provided in all parts of the hiring process as required under Adecco’s Employment Accommodation policy. Applicants will need to make their needs known in advance to their Adecco representative.**