Market Quality Associate - #94862

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

This position is responsible for processing and coordinating the review of medical device complaints in accordance with requirements from Health Canada and enable Olympus to investigate and report to applicable international regulatory bodies. The individual will support the continuous improvement efforts of the Quality System for processing complaints in order to meet Health Canada, FDA, ISO and all applicable international regulatory requirements and corporate guidelines. Performs special assignments upon request

Job Duties

• Enters and process complaint information received from internal and external sources into complaint handling databases as appropriate.
• Interface with internal and external customers to obtain additional information to facilitate complaint investigation by the manufacturer.
• Documents all communication in compliance with department procedures.
• Coordinates with internal and external customers, such as Operations, Service and international Olympus personnel, to support timely failure investigation.
• Evaluate complaints against Mandatory Problem Reporting requirements to Health Canada and other applicable regulatory agencies.
• Prepare and submits Mandatory Problem Reports for review in a timely manner.
• Files Preliminary and Final MPRs with Health Canada.
• Monitor and prepare work in progress reports and key performance indicators regularly.
• Manage and update complaints throughout file lifecycle.
• Document applicable elements of the complaint handling process, such as contact records with external customers, database updates, and complaint closure letters.
• Occasionally interface with Health Canada and other regulatory agencies regarding complaints.
• Improves the complaint handling process and routine tasks for better efficiency and greater integrity.
• Support and maintain the Quality Managem.

Job Qualification

Required:

• Post secondary education in Scientific, Clinical, Biomedical, or Engineering discipline, or equivalent knowledge.
• Minimum 2 years of experience within Medical Device,

Preferred:

• Bilingualism (English and French) preferred.
• Pharmaceutical or hospital environment, with strong concentration in compliance and/or quality assurance preferred.
• Capable of working independently with general instructions from manager while following SOP, corporate policies and regulatory requirements.
• Strong analytical, organizational and communication skills required · Must be able to multitask and meet deadlines on multiple projects.
• Strong attention to detail and accuracy are required.
• Must be able to demonstrate a working proficiency in operating a personal computer and perform basic word processing spreadsheet tasks using Microsoft Excel and Word applications.
• Knowledge of Canadian Medical Devices Regulation, FDA Quality System Regulations and ISO 13485 preferred.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries and annual bonus program
• Comprehensive medical benefits and pension plan
• Tuition reimbursement
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• Parental Leave and Adoption Assistance
• Diversity & Inclusion Programs including Colleague Affinity Networks

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

Olympus Canada Inc. (OCI)—a subsidiary of Olympus Corporation of the Americas—manages the Company’s operations and workforce throughout Canada in roles such as sales, marketing, service, and support functions. Based in Richmond Hill, ON, OCI is committed to developing our employees and supporting our local communities. For more information, visit olympuscanada.com and truetolife.com.

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.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, provincial or local protected classification. EOE Minorities/Females/Veterans/Disabled

Posting Notes: || Canada (CA) || Ontario (CA-ON) || Richmond Hill ||