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QA/quality Control Manager - Georgetown, Canada - Communications and Power Ind. Canada Inc

Communications and Power Ind. Canada Inc

Verified Company

Georgetown, Canada

1 month ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Primary Responsibilities

Responsible for the development, implementation and maintenance of the site Quality Management System (QMS) transition, and periodically provides reports on the performance of the QMS along with recommendations for improvement to senior management.
Develops and maintains a current Quality Manual System Manual and current Standard Operating Procedures (SOPs), guidelines, standards and records.
Responsible for controlling new and revised documents required for the operation of the QMS pursuant to the Quality Management System Manual. Please see Manual for detailed outline of responsibilities.
Develops staff and drives new approaches to Quality Assurance and Quality Management principles, theories, concepts and techniques.
Develops a system for management of technical product complaints.
Reviews and approves SOPs, protocols, reports, and production batch records.
Leads and manages the day to day activities of all quality assurance personnel and ensures the efficiency and effectiveness of all onsite quality system activities maintaining compliance with the Quality System Regulations, cGMP and industry standards.
Designs and implements Quality Assurance training programs for key relevant personnel. Provides quality "on the floor" support for all Operations.
Manages Corrective and Preventive Action System, Document Review/Traceability Release function, Final Product Disposition, and Labels.
Represents Quality Assurance and Quality Control on crossfunctional teams participating in various operational programs such as process development, risk management activities, validation planning, LEAN improvements, and other continuous improvement activities.
Reviews and approves deviations / nonconformances. Establishes effective Corrective Action Plans of all the Operations department nonconformances. Drive towards timely closure and effectiveness
Leads, supports, and participates with the Operations functions to proactively investigate, identify, and implement bestinclass quality manufacturing practices
Provides support to audits and regulatory inspections and ensures the execution of Corrective Action and compliance with internal quality procedures and external standards. Generates audit reports, opportunities for improvement and other QA documents as required.
Conducts investigations and internal audits of procedures, forms and all associated documents consistent with EHS practices and guidelines.
Initiates CAR's or PAR's as needed.
Conducts compliance inspections and audits of contract manufacturers and vendors/suppliers of products. Prepare reports of investigations or audits findings of contract manufacturers and vendors/suppliers and follows through with supplier for corrective actions
Manages equipment and tooling calibration for the facility

Position Requirements

Bachelor's degree in engineering with specific course work in the quality sciences (e.g., Statistical Process Control [SPC], Compliance Engineering) is an asset.
Six (6) to eight (8) years of related quality/reliability/product development engineering experience.
Five (5) to eight (8) years managing quality and/or other multidisciplinary staff in a manufacturing environment
Practical experience with risk management, product testing, capability studies, and control plans
Ability to create and review technical documentation, including project plans, test procedures, and design documents.
Ability to develop, review, and maintain metrics and quality audits.
Strong problem identification and problem resolution skills
Solid knowledge of ISO9001 and ISO 13485 standards and requirements for CE Marking
Familiarity with Federal Aviation Regulation Part 145, DO160G airborne qualification testing and AS9100 would be an asset
Experience with European MDD/MDR, United States FDA and Health Canada regulations for medical devices would be an n asset
Knowledge of Environment regulatory requirements: EPA-TSCA, REACH, (EU) Waste Framework Directive, RoHS would be an asset
Training and knowledge of Six Sigma techniques and Lean Manufacturing are desirable.
Highly motivated and selfdirected capable of multitasking, and able to work with mínimal supervision.
Extremely detailoriented and analytical thinker.
A welldefined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills and ability to interface directly with crossfunctional teams