Quality Management System Specialist - Contract

Olympus Corporation; Richmond Hill; Hybrid; CAD 61,000 - 82,000; Full time

Job summary

Olympus Corporation in Ontario, Richmond Hill, is seeking a contract Quality & Regulatory Affairs professional to maintain and continuously improve the site Quality Management System (QMS) to ensure compliance with ISO 13485, Health Canada regulations, and global quality standards, enabling safe, effective patient care.

You will serve as the site subject matter expert for quality processes including CAPA, NCR, audits, change control, document control and training.

Qualifications

• Bachelor’s degree in engineering, science, quality, life sciences, or related field.
• Minimum of 3 years in medical devices or a regulated industry.
• Experience with CAPA, NCR, audits, change control, and training required.

Responsibilities

• Support global quality initiatives and harmonization activities.
• Analyze quality metrics, identify trends, and prepare Management Review reports.
• Develop, maintain and improve QMS processes, procedures, and work instructions.
• Support investigations, root cause analysis, risk assessments within NCR/CAPA/DEV programs.
• Administer CAPA, NCR, Audit, Change Control, Training, and Document Control programs.
• Ensure CAPA/NCR/Audit execution is governed and monitored to drive patient centric risk decisions demonstrated in objective evidence and timely closure.
• Support regulatory inspections, customer audits, internal audits and inspection readiness activities.
• Drive continuous improvement projects to improve compliance and process effectiveness.
• Perform special assignments as directed.

Skills

CAPA & NCR processes

Audit & inspection readiness

Risk assessment & root cause analysis

Regulatory compliance understanding

Documentation control

Education

Bachelor’s degree in Engineering, Science, Quality, Life Sciences, or related

Tools

CAPA system

NCR process

Audit management

Change Control

Document Control

Training management

Microsoft 365

Job description

Working Location: Ontario, Richmond Hill

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers .

Job Description

This is a 13-14 month contract position.

This role is responsible for maintaining and continuously improving the site Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, ISO 13485, Health Canada regulations, company policies, and global quality standards.

This role serves as the site subject matter expert for quality system processes including CAPA, NCR, Audits, Change Control, Document Control, Training, and Management Review. The position partners with cross-functional teams to drive compliance, inspection readiness, risk reduction, and continuous improvement.

Job Duties

• Support implementation of global quality initiatives and harmonization activities.
• Analyze quality metrics, identify trends, and prepare Management Review reports.
• Develop, maintain and improve QMS processes, procedures, and work instructions.
• Support investigations, root cause analysis, risk assessments within NCR/CAPA/DEV programs.
• Administer CAPA, NCR, Audit, Change Control, Training, and Document Control programs.
• Ensure CAPA/NCR/Audit execution is governed and monitored to drive patient centric risk decisions demonstrated in objective evidence and timely closure.
• Support regulatory inspections, customer audits, internal audits and inspection readiness activities.
• Drive continuous improvement projects to improve compliance and process effectiveness.
• Perform special assignments as directed.

Job Qualifications

Required:

• Bachelor’s degree required in Engineering, Science, Quality, Life Sciences, or related technical discipline.
• Minimum of 3 years of experience in medical devices or another regulated industry required.
• Experience with CAPA, NCR, Audit, Change Control, Document Control, and Training processes required.
• Working knowledge of ISO 13485, FDA QMSR/QSR, Health Canada regulations, risk management principles, root cause analysis methodologies, quality data analysis, and Microsoft 365 applications.
• Occasional support outside normal business hours for audits, inspections, and global projects.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus
• Comprehensive medical benefits and pension plan
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks .

The anticipated starting base pay range for this full-time position working at this location is $60,823.00 - $82,111.00 plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

Artificial Intelligence is not being utilized in the Olympus hiring process.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations:

Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || Canada (CA) || Ontario (CA-ON) || Richmond Hill || Quality & Regulatory Affairs (QA/RA)