Senior Specialist, Quality Management SystemStryker • Hamilton, ON, CA

Senior Specialist, Quality Management System

Stryker • Hamilton, ON, CA

7 days ago

Job type

Full-time

Job description

Overview

Job Overview : This position is responsible for the development of the quality management system in accordance with ISO standards, Good Manufacturing Practices (GMP), Stryker Corporate requirements, and Canadian regulatory requirements. This individual is responsible for oversight, support, and ensuring that an effective and efficient quality management system is built and maintained. This individual must serve as a contributing member of the Quality Assurance team while championing Stryker’s Mission and Values.

Responsibilities

Individual Responsibilities :

Proactively collaborates with internal and external stakeholders to promote a culture of inclusiveness and cooperation
Live and exemplify Stryker’s Values : Integrity, Accountability, People, and Performance

Functional Responsibilities :

Support Quality Management System (QMS) compliance with the appropriate internal and external regulatory requirements (including but not limited to ISO 9001, Stryker Corporate, Stryker Canada, and Health Canada requirements)

Contribute to the development of optimum future state of the QMS for business needs

Identify improvements and inputs into the quality planning process

Oversee and execute development and / or modification of Stryker Canada’s QMS

Support Management Review and Quality Planning Review and related forums to ensure and monitor QMS suitability, adequacy and effectiveness

Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS

Ensure quality records are established and maintained to provide evidence that the QMS is being followed

Implement and maintain the internal audit and self-inspection programs covering all processes, products, and regulations within scope of the QMS

Liaise with external assessment bodies and health authorities on all matters related to the external certification process and compliance to the Canadian regulations

Responsible for review and approval of NCs and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, and effectivity, and timelines along with review and approval of CAPA changes and extension requests

Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process

Ensure rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner

Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 5 Why's, fishbone diagrams, 4D’s, process mapping, etc.)

Provide leadership to drive behaviours through the use of accountability meetings and facilitate root cause analysis workshops with process owners to ensure timely CAPA investigation and closure.

Lead and execute the NC / CAPA review board and maintenance for relevant KPIs

Support the creation of quality objectives / KPI’s across the business, and provide support in meeting requirements / targets

Contribute to the development, maintenance, and improvements of policies and procedures

Implement best-in-class practices and benchmark against industry and regulatory requirements

Drive Good Manufacturing Practices and Good Documentation Practices within the organization

Other duties as assigned by Manager

Conduct & Compliance

Abide by and support the policies set forth in the Stryker Code of Conduct

Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker

Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards

Report any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline Policy

Knowledge & Skill Requirements

Working knowledge of ISO 9001 requirements

Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics

Strong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an asset

High standard of integrity and ability to meet deadlines

Highly organized and able to prioritize tasks

Project management and report writing; preferable

Strong oral and written communication skills with both internal and external contacts

Ability to make and support decisions with regards to regulatory and quality issues

Education & Qualifications

University Degree required

Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred

Minimum 3+ years’ experience in regulatory affairs and / or quality assurance

Experience in regulated environment and interaction with auditing authorities and health authorities required

$75,000.00 - $99,500.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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Senior Specialist Quality Management System • Hamilton, ON, CA

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