Quality and Continuous Improvement Manager

Description

Position Overview:
The Quality Assurance (QA) and Continuous Improvement Manager ensures that quality standards and procedures are met and aligned with legislation and customer specifications for medical, communications and airborne products. This individual is responsible for managing the organization’s quality assurance policies, administering the organization’s quality management system, and ensuring regulatory compliance. The QA Manager will also establish performance standards, procedures, and audit controls to address business requirements, as well as identify and implement process improvements to increase the efficiency, effectiveness, and quality of company operations.

Primary Responsibilities
- Provide leadership developing, and directing, QA and continuous improvement initiatives through Operational Excellence for all company products and services.
- Monitor QA systems and advise executive team on system performance; publish metrics regarding performance against set goals.
- Manage activities for QA, Regulatory Specialist, Final Inspection, Receiving Inspection, and calibration teams
- Establish and maintain a QA program for monitoring supplier quality, and equipment calibration including audits, controls, and corrective and preventative actions.
- Collaborate with client-facing QA representatives to ensure full customer satisfaction with the company's products and services.
- Act as liaison with customer auditors and assume responsibility for ensuring corrective actions with customer specifications.
- Lead internal audits, identify gaps, and drive corrective actions to close the gaps in a timely manner.
- Ensure compliance to industry standards, government regulations, and customer requirements.
- Conduct risk analyses, verification, validation activities, and formal design reviews, as applicable.
- Support new product development and continuous improvement by integrating quality control tools (e.g. Lean, Six Sigma, etc.) into processes.
- Promote and advocate quality achievement and performance improvement across the organization.
- Engage staff to adopt and incorporate quality methods into their work
- Identify or develop and document QA best practices
- Provide oversight on product change control processes within the operations.
- Maintain a constant awareness of company profitability, including budgetary control issues.
- Manage and grow the quality team by fostering inclusion and collaboration. Maintain a team skills matrix and identify training and growth opportunities.

**Requirements**:
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.
- 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, DO-160G 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 self-directed capable of multi-tasking, and able to work with mínimal supervision.
- Strong work ethic and positive team attitude.
- Extremely detail-oriented and analytical thinker.
- A well-defined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills.
- Able to build and maintain solid relationships with key business partners, and government agencies
- Ability to interface directly with cross-functional teams