Quality Assurance Specialist

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Topcon is presently looking for a Quality Assurance Specialist.  Reporting to the QA Sr Manager, The Quality Assurance Specialist will support Complaints and CAPAs handling as well as nonconformance investigations, to ensure company compliance according to Regulatory and internal requirements.

Responsibilities:

• Responsible for analyzing and investigating product complaints or reported quality issues to ensure handling and closure in accordance with company guidelines and external regulatory requirements.
• Manages timelines for complaint investigations to ensure timely reporting and resolution.
• Identify applicable corrective and preventive actions to facilitate complaints closure.
• Evaluates issues against product and device history for the identification of root causes and trends.
• Maintains and analyzes problems’ log to identify recurrent issues and reports them to the QA management.
• Provides technical input for medical device adverse event evaluation.
• Participates in cross-functional teams to investigate potentially reportable events or those with potential business impact.
• Works with Operations department to establish a proper clear documentation of the complaint by identifying and advising of any related field failure data.
• Collaborate in the compilation of complaints data and in the preparation of complaints metrics and trend reports in support of Quality Review Board and Management Review.
• Work closely with internal departments for an adequate complaints handling, resolution of CAPAs and Supplier Corrective Action Requests.
• May assist in internal and Regulatory audits.
• Assist in other Quality Assurance tasks as required.

Requirements:

Education & Experience:

• Bachelor or higher degree in a science related field.
• 2 years or more of progressive quality assurance background in medical device.
• Hands-on experience in complaint processing in a regulated manufacturing environment (pharmaceutical, medical devices, etc.).

Knowledge, technical Skills, Abilities:

• Quality thinking oriented.
• Working knowledges on Health Canada regulations, ISO 13485 MDR, and applicable global regulatory requirements for complaints handling.
• Possess strong analytical skills (tracking, trending, analyzing, reporting) with a thorough understanding of database environments.
• Software Proficiency with an extensive knowledge and experience in utilizing standard software systems.
• Familiarity with Complaints handling is an asset.

Language skills:

• Excellent verbal and written communication skills with a demonstrated ability to communicate clearly and professionally.
• Fluency in French is an important asset.

Base Pay:

Expected Base Pay Range: $60,000 to $80,000 Annualized

The base pay range included is a projected hiring range for a position, level and potential work location(s) listed.  Topcon provides the compensation range that it in good faith believes it might pay and/or offer for this position. This compensation range is based on a full-time schedule.

Benefits* :

Topcon offers a comprehensive benefit package for this position including medical, dental, vision, life insurance, disability insurance, tax saving spending accounts a 401(k) plan with employer match, tuition reimbursement in addition to other perks and benefits.  We also offer time off for our employees to recharge.  Our employees are eligible for paid company holidays, paid personal time off, and paid sick time that meets or exceeds state/local requirements.

Topcon reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation; individual candidate compensation may be determined based on individual skills, experience, training, certifications, education, final work location and other factors not related to an applicant’s sex or other status protected by local, state, or federal law. Changes in the position level, location or other factors associated with the role may change the final determined compensation.  The recruiter can provide additional information during the hiring process.

*Topcon time off policies can vary between roles which are exempt or non-exempt.  For hourly (“non-exempt”) employees, we offer personal paid time off which accrues in accordance with local standards.  For salaried (“exempt”) employees, we offer a flexible paid time off policy giving you flexibility to take time when needed, while supporting business needs.  All paid time off policies are in accordance with or exceeding local law.  Employees working at least 30 hours per week are eligible for our Health and Welfare benefit package.

EEO Statement:

We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.