Market Quality Associate - Richmond Hill, Canada - Olympus Corporation of the Americas

Olympus Corporation of the Americas

Verified Company

Richmond Hill, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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.

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.
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 ondemand wellness classes
Worklife 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 mínimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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) || Rich