Contract, Senior Analyst, Market Quality

Olympus Corporation of the Americas; Toronto; Hybrid; CAD 70,000 - 100,000; Full time

Job summary

Olympus Corporation of the Americas seeks a Market Quality Sr. Analyst in Toronto for an 18-month maternity cover. Responsibilities include managing post-market activities for complaints and ensuring regulatory compliance. Qualified candidates should have significant experience in medical devices and strong analytical skills.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical, dental, vision coverage

Employee Assistance Program

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance

On-Site Child Daycare, Café, Fitness Center

Qualifications

• Minimum 5 years of complaint handling experience in medical device manufacturing.
• Strong knowledge of regulatory compliance and quality assurance.
• Familiarity with complaint handling databases.

Responsibilities

• Evaluate and process complaints for regulatory reporting.
• Support quality records preparation for regulatory submissions.
• Interact with internal and external customers for complaint investigation.

Skills

Analytical skills

Organizational skills

Communication skills

Education

Associate Degree of Science, Engineering, or Scientific discipline

Tools

ISO 13485

Canadian Medical Device Regulations

FDA Quality System Regulations

Job description

Working Location:Ontario, Toronto

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 ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our fiveCore Valuesempower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus.

Job Description

(This is a fixed-term maternity cover position for a period of up to 18 months.)

As a Market Quality Sr. Analyst OCI-OSTA team member, you will be responsible for performing timely post market activities for Canadian North American complaints that require evaluation, assessment, and/or follow-up for regulatory reporting determinations and regulatory submissions. The MQ Analyst Sr. will evaluate complaints and communicate with Field Specialists, Sales Representatives, Field Service Employees, Engineers, Technicians, Clinicians, and Customers directly as well as utilize different data sources in order to understand the facts and details around the complaints. Performs routine assignments with direction from management the supervisor as needed; requires general instruction for new or special assignments from the management. Supervisor. The MQ Analyst Sr. will maintain quality documents to ensure compliance with medical device guidance documents. The MQ Sr. Analyst should be familiar with Medical Device Quality Systems regulations including ISO 13485 the Canadian Medical Device Regulations (SOR/98-282).

Job Duties

• Routes, process, and reviews complaints assigned daily for reportability.
• Evaluate complaints against Mandatory Problem Reporting/Incident Reporting requirements to Health Canada and other applicable regulatory agencies. Prepare and submits Mandatory Problem Reports/Incident Reports in a timely manner. Files Preliminary Update and Final MPR/Incident Reports with Health Canada.
• Route and process complaint information received from internal and external sources into complaint handling databases as appropriate.
• Support routing and review of ancillary system sources information to ensure complaint records are accurate—facilitate exchange of information from ancillary system sources to the Complaint Handling System and supporting teams where necessary.
• Provide MDR Submission team with quality records in support of preparation for submission to FDA and/or Health Canada.
• Assist in due diligence and good faith effort attempt activities to drive complaint investigation closure timeliness per established local and global metrics.
• Determine whether additional information is required in order to make a preliminary MDR/MPR file/no file decision.
• Where appropriate in legacy complaint handling systems, review reported event description and ensure intake code is aligned with event and accurate. Review all final codes and ensure accuracy 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 and facilitate timely failure and complaint investigation.
• Monitor and prepare work in progress and safety net reports and key performance indicators regularly in support of Complaint Handling and adverse event reporting metrics.
• Manage and update complaints throughout lifecycle. Document applicable elements of the complaint handling process, such as contact records with external customers, database updates, and complaint closure letters.
• Interface with Health Canada and other regulatory agencies regarding complaints and complaint investigations – lead responses with Health Canada and other regulatory agencies regarding complaints and complaint investigations.
• Lead late adverse event reporting and complaint handling timeliness excursions from target KPIs in support of applicable non-conformance and CAPA quality files.
• Drive improvements to the complaint handling process and routine tasks for better efficiency and greater integrity.
• Support and maintain the Quality Management System at Olympus Corporations of the Americas.
• Other assigned task and duties as assigned by supervisor management.
• Perform other related duties as required.

Job Qualifications

Required:

• Associate Degree of Science, Engineering, or Scientific discipline, or equivalent knowledge/experience recommended.
• Minimum of 5 years of complaint handling experience within medical device manufacturing environment, with strong concentration in regulatory compliance and/or quality assurance.
• Strong analytical, organizational and communication skills required.
• Knowledge of FDA Quality System Regulations Canadian Medical Device Regulations (SOR/98-282), FDA Quality System Regulations 21CFR803/820 and ISO 13488/13485.
• Hepatitis B vaccination is recommended for employees who are at risk for exposure to blood or other bodily fluids on the job. Service responsibilities include the handling of products and equipment that may have potentially come into contact with blood or bodily fluids. OCI requires that all employees working in areas that may be exposed to this risk, either provide proof of the Twinrix (Hepatitis A and B) vaccination or sign a waiver accepting the possible risk of exposure from not being vaccinated. If you have severe allergies or ever had a severe allergic reaction to a vaccine please seek medical advice before taking this vaccine.

Preferred:

• Previous supervisor/ team lead exp.erience preferred

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 and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

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

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

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 value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

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) || Toronto ||Quality & Regulatory Affairs (QA/RA)