Stryker Corporation

Senior Specialist, Operations Quality

Stryker Corporation • $72K — $96K *
Hamilton, ON L8L 0A2In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

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
  • Experience in Medical Device and/or Pharmaceuticals is an asset
  • Strong understanding of ISO 9001 and Canadian medical regulations
  • Proficiency in Excel, Word, PowerPoint, SharePoint; familiarity with Trackwise and ComplianceWire is a plus
  • Excellent oral and written communication skills

Responsibilities

  • Collaborate with stakeholders to foster a culture of inclusiveness
  • Act as the primary contact for Quality activities within Operations for Stryker Canada
  • Contribute to quality planning by identifying improvement opportunities
  • Represent QA on Operations-led projects as a key stakeholder
  • Review processes affecting the Quality Management System for regulated product distribution
  • Implement and maintain the Validation Program in collaboration with Operations
  • Provide support and oversight for Non-Conformances and Corrective and Preventive Actions (CAPAs)

Benefits

  • Hybrid work flexibility
  • Opportunities for professional development and training
  • Inclusive and cooperative workplace culture
  • Contribution to impactful and meaningful work in quality assurance and healthcare
  • Alignment with high ethical standards and compliance policies
Full Job Description
Work Flexibility: Hybrid

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

  

 

Travel Percentage: None

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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