Manager, Quality Assurance

Stryker is hiring a Manager, Quality Assurance in Burnaby, British Columbia to support our Endoscopy business! In this role, you will lead the Quality Assurance team with focus on Quality Assurance activities with responsibility for delivering key quality and compliance results for the site operations.

What you will do:

• Leads Quality Assurance team and is responsible for product and process performance and continuous improvement of quality assurance programs.

• Drives programs and initiatives aimed to achieve product performance targets in areas such as first pass yields, process DPM, manufacturing loss and complaint levels.

• Partner with SQ teams to reduce supplier DPM and achieve targets.

• Supports all functions of the QA team personnel including (but are not limited to): risk analysis / mitigation strategies, production control functions, NC/CAPA activities, quality system improvements, audit support (both internal and external), etc.

• Ensures that the organization’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory agencies.

• Ensures effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise.

• Fosters a continuous improvement approach to Quality, ensuring that quality is the responsibility of all site employees.

• Ensures quality systems are developed, implemented and continuously reviewed to ensure compliance with all applicable regulatory requirements

• Responsible for executing internal and external agency site audits/inspections. May serve as Management Representative for the site and presents to Management with Executive Responsibility regularly on the status of the company’s QMS.

• Participates as a member of the Site Leadership Team in the development and implementation of business strategy and objectives.

• Creates a highly talented and high performing Quality Assurance team. Selects talent and supports the development of their future potential. Ensures effective training and performance management of the teams.

• Champions a positive employee relations environment by promoting open communication, engagement and development of team members. Promotes a culture of inclusiveness, trust, flexibility and teamwork.

• Develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality, reduce cost, decrease in-efficiency and improve risk management.

What you need:

Required:

• Candidate must have successfully completed a BS of Engineering, Science or equivalent related qualification.

• 8+ years of experience in Quality Assurance, Manufacturing, Engineering, or relevant experience in a regulated industry.

Preferred:

• 5+ years’ people management experience and a proven track record of successfully creating and managing highly talented, engaged and performing teams is preferred.

• Ability to implement organization and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level).

• Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously. · The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines. Demonstrated Initiative.

• Self-starter with demonstrated efficient work methods, high analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

•  Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies. ·

• Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.

• Must be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.

• Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency at all times.