Quality Assurance – Diagnostic Advisor
Luxottica
Requisition ID: 864271
Store #: EC0538 ESS – TOR Lab Oper Dept-TORHM
Position:Full-Time
Total Rewards: Benefits/Incentive Information
Vision Associates is the nation’s leading optical dispensary management & consulting company. Our mission is provide the highest level of service and integrity. Our extensive background in the optical industry enables us to provide solutions that promote growth and profitability. In partnership with our clients’, our foremost objective is to deliver complete and comprehensive service that reflects our commitment to eye care excellence.
Everyday we feel inspired to ignite our passion for patient care. Our people work closely with doctors, learn from complex medical cases, and make a difference in patients’ lives. We unleash the power of optical.
Vision Associates is part of EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.
GENERAL FUNCTION
Based in our Toronto office, reporting to the Director – Industrial lab, this role will work from 8:30 am to 05:00 pm, Monday to Friday (40 hours per week), with flexibility based on business requirements.
The Quality Coordinator will support the ongoing compliance and maintenance of the Quality Management System (QMS) in line with ISO 13485:2016 standards at an optical lens manufacturing site. This role is critical in ensuring product quality and process efficiency, driving continuous improvement, and maintaining adherence to all regulatory requirements. The successful candidate will play a key role in coordinating quality assurance activities, internal audits, and corrective action plans while collaborating with cross-functional teams to ensure that products meet customer specifications and regulatory standards.
MAJOR DUTIES AND RESPONSIBILITIES
- Ensure Compliance with ISO 13485:2016: Maintain and update the QMS, ensuring alignment with ISO 13485:2016 certification requirements and other applicable regulatory standards.
- Quality Control & Audits: Organize and conduct internal quality audits, and assist in external audits. Ensure that all non-conformities are documented and resolved effectively.
- Document Control: Manage and maintain quality documentation, including standard operating procedures (SOPs), work instructions, and records related to production and quality.
- Process Improvement: Collaborate with production, engineering, and other departments to identify areas for quality improvement, optimize processes, and reduce defects.
- Training & Support: Provide training to staff on quality procedures, regulatory requirements, and QMS updates. Act as the first point of contact for quality-related issues and investigations.
- Corrective and Preventive Actions (CAPA): Investigate product and process deviations, root causes, and ensure timely implementation of corrective and preventive actions.
- Customer Complaints: Assist in the investigation and resolution of customer complaints related to product quality, ensuring prompt corrective measures.
- Data Analysis & Reporting: Collect, analyze, and report key quality metrics, including product defects, audit findings, and process improvements, to track overall performance.
- Regulatory Updates: Stay up to date with changes in regulations and standards, ensuring the QMS reflects any necessary updates.
BASIC QUALIFICATIONS
- Bachelor’s degree in a related field (Quality, Engineering, or Life Sciences) or equivalent experience.
- Minimum of 2-3 years of experience in quality assurance or a similar role, preferably in a manufacturing environment.
- In-depth knowledge of ISO 13485:2016 requirements and implementation.
- Experience with QMS, document control, and audit procedures.
- Strong analytical and problem-solving skills.
- Excellent communication skills, both verbal and written.
- Ability to work cross-functionally with various departments and teams.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
PREFERRED QUALIFICATIONS
- Experience in the optical or medical device manufacturing industry.
- Certification in quality management systems (e.g., Certified Quality Auditor (CQA) or similar).
- Familiarity with lean manufacturing and continuous improvement methodologies.
Working Conditions:
This role will primarily be based in a manufacturing environment with exposure to production areas. Some travel may be required for external audits and training.
Pay Range: – 95,393.12
Employee pay is determined by multiple factors, including geography, experience, qualifications, skills and local minimum wage requirements. In addition, you may also be offered a competitive bonus and/or commission plan, which complements a first-class total rewards package. Benefits may include health care, retirement savings, paid time off/vacation, and various employee discounts.
Upon request and consistent with applicable laws, EssilorLuxottica will provide reasonable accommodations to individuals with disabilities who need assistance in the application and hiring process. To request a reasonable accommodation, please call the EssilorLuxottica SpeakUp Hotline at 844-303-0229 ( (be sure to provide your name and contact information so that we may follow up in a timely manner) or email HRCompliance@luxotticaretail.com.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, national origin, social origin, social condition, being perceived as a victim of domestic violence, sexual aggression or stalking, religion, age, disability, sexual orientation, gender identity or expression, citizenship, ancestry, veteran or military status, marital status, pregnancy (including unlawful discrimination on the basis of a legally protected pregnancy or maternity leave), genetic information or any other characteristics protected by law. Native Americans in the US receive preference in accordance with Tribal Law.