Senior Specialist, Operations Quality

Stryker Group; Hamilton; On-site; CAD 72,000 - 97,000; Full time

Job summary

Stryker Group in Canada seeks a Senior Specialist, Operations Quality to support and maintain the Quality Management System in line with ISO standards, GMP, and Canadian regulatory requirements. The role collaborates with Global Logistics & Operations and serves as QA liaison on Operations projects.

The ideal candidate has a university degree in science/engineering, a QA/RegAff credential, and 3+ years in regulatory affairs or QA, with familiarity in medical devices and pharmaceuticals.

Qualifications

• University degree in Science, Engineering or related field.
• Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred.
• Minimum 3+ years’ experience in regulatory affairs and/or quality assurance.
• Medical Device and/or Pharmaceutical experience is an asset.
• Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered.

Responsibilities

• Proactively collaborates with internal and external stakeholders to promote a culture of inclusiveness and cooperation.
• Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance.
• Act as the key contact for Quality related activities within Operations for Stryker Canada.
• Identify improvements and inputs into the quality planning process.
• Represent QA and act as the QA stakeholder on Operations-led projects.
• Responsible for the review of programs and/or processes impacting the Quality Management System governing the distribution of regulated products within Canada.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of QMS related documents for Operations.
• Ensure quality records are established and maintained to provide evidence that the QMS is being followed.
• Implement and maintain the Validation Program in collaboration with Operations and GLO for Stryker Canada.
• Provide oversight for the development and/or execution of plans, protocols, reporting, training and quality system documents associated with validation requirements.
• Responsible for the support and review of NCs and CAPAs for Operations, with attention to detail, review for completeness of actions and records, accuracy, and effectivity, and timelines.
• Facilitate Operations teams in the application of problem-solving techniques and promote its uses and development (e.g. 5 Why's, fishbone diagrams, 4D’s, process mapping, etc.)
• Support the creation of quality objectives/KPI’s for Operations, and provide support in meeting requirements/targets
• Drive Good Manufacturing Practices and Good Documentation Practices within Operations
• Other duties as assigned by Manager
• 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

Skills

ISO 9001 requirements

Canadian medical device regulations

Advanced computer skills

Integrity & deadline driven

Highly organized & prioritization

Project management & reporting

Strong communication skills

Education

University degree in Science/Engineering

Post-graduate diploma in Regulatory Affairs or QA

Tools

TrackWise

Job description

Senior Specialist, Operations Quality

This position is responsible for providing dedicated support to Operations to develop and maintain those areas 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 to support and ensure that effective and efficient quality practices are maintained in collaboration with Global Logistics & Operations (GLO). 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

• Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance

Functional Responsibilities:

• Act as the key contact for Quality related activities within Operations for Stryker Canada

• Identify improvements and inputs into the quality planning process

• Represent QA and act as the QA stakeholder on Operations-led projects

• Responsible for the review of programs and/or processes impacting the Quality Management System governing the distribution of regulated products within Canada

• Identify and implement improvement opportunities to increase the efficiency and effectiveness of QMS related documents for Operations

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

• Implement and maintain the Validation Program in collaboration with Operations and GLO for Stryker Canada

• Provide oversight for the development and/or execution of plans, protocols, reporting, training and quality system documents associated with validation requirements

• Responsible for the support and review of NCs and CAPAs for Operations, with attention to detail, review for completeness of actions and records, accuracy, and effectivity, and timelines

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

• Support the creation of quality objectives/KPI’s for Operations, and provide support in meeting requirements/targets

• Drive Good Manufacturing Practices and Good Documentation Practices within Operations

• 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

Education & Qualifications

• University degree in Science, Engineering or related field required

• Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred

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

• Medical Device and/or Pharmaceutical experience is an asset

• Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered

Canada Pay Ranges:

• Canada: $72,400 - $96,600 CAD Annual