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Manager, Quality Assurance
| Location: | Richmond Hill, York, Toronto, Ontario, Canada |
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| Job Type: | Permanent |
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| Posted: | 21st Jul 2008 |
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| Closing Date: | 4th Aug 2008 |
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| Posted By: | GeneNews Corporation |
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| Details: | |
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Manager, Quality Assurance
Reporting to the Director, Operations, the Manager, Quality Assurance will manage and coach the Quality Assurance team, lead the on-going development of the GeneNews Quality Management System, and monitor key quality indices and identify opportunities for improvement. The Manager, Quality Assurance will also direct the quality planning activities identifying changes necessary due to new or revised regulations or standards.
Duties and Responsibilities (include but are not limited to):
Quality Management System
* Direct the ongoing development of the GeneNews Quality Management System;
* Act as the Management Representative;
Support development of ColonSentry IVD and LDT; and
* Support the certification of GeneNews to CLIA and ISO 15189.
Management Activities
* Provide direction to peers on Quality related training;
Maintain and execute Quality Management System planning;
* Maintain and communicate Quality metrics to Executive Management and employees;
* Ensure ongoing compliance of the Quality Management System with regulatory and ISO standards requirements;
* Interview, select, hire and train employees for or on the Quality Assurance team;
* Set departmental and individual performance goals and provide appropriate feedback;
* Direct and coach the activities of the Quality Assurance team;
* Oversee Quality Management System training activities; and
Manage the operational and fiscal activities of the department including staffing levels, budgets, and financial goals.
Communication
* Interacts with customers, directors, other managers, employees within Quality Assurance and other functional areas; and
* Review and provide technical expertise for work instructions.
* Other related duties and responsibilities as assigned.
Key Qualifications, Skills and Abilities:
* BSc. or equivalent in biological sciences or quality assurance.
* 9 -12 years related experience in a medical device environment, and a minimum of 5 years experience in a management capacity.
* Good understanding of ISO 14971 (Medical devices – Application of risk management to medical devices); ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes); FDA Medical Device Regulations; Good Laboratory Practice (GLP); Good Manufacturing Practice (GMP); Canadian Medical Device Regulations.
* Knowledge of TDG (Transportation of Dangerous Goods, CAN), DOT (Department of Transportation, U.S.), and IATA (International Air Transport Association) regulations.
* Research and development laboratory experience is an asset.
* Ability to solve problems that are diverse in scope.
Ability to exercise judgment and determine appropriate action.
* Experience developing performance standards and requirements.
* Ability and aptitude to work in a dynamic environment.
Excellent oral and written communication skills.
* Ability and knowledge to assess applicability of regulations as it pertains to GeneNews’ processes and development activities.
* Ability to make decisions that have direct impact on employees and implementation of regulatory requirements.
* Strong computer skills (MS Office applications and Internet).
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