Job DescriptionWorking Location: Ontario, Richmond HillWorkplace Flexibility: HybridContract: 18‐month assignmentThe Manager, Site Quality System provides leadership at the location to ensure QMS compliance with regulatory requirements and aligns with the company's business strategy. The role acts as the Quality Leader, delivering training and mentoring across procurement, manufacturing, returns and servicing of products, and champions continuous improvement within the Global Quality Management System.Job DutiesServe as the Management Representative for the location.Establish department objectives to meet quality objectives, organizational goals and strategic plans.Manage staff development and performance.Oversee facility audits by external agencies (Health Canada, Notified Bodies, FDA) and internal Olympus compliance groups.Ensure audit deficiencies are corrected per policy.Lead management reviews as per policy.Champion development, implementation, and continuous improvement of the Quality Management System.Ensure the QMS is effectively maintained within the organization.Develop and revise policies, SOPs, and work instructions as needed.Manage processes related to product quality throughout the lifecycle.Champion quality systems and tools such as CAPA, Non‐Conformance Reporting, and audit activities.Manage change control and document control activities.Manage ship hold processes.Coordinate training programs on the company's quality system(s) across all departments.Develop and execute strategies for addressing quality issues and communicate recommendations.Assist in evaluation and qualification of suppliers, manufacturers, and vendors.Oversee maintenance and control of quality documents, business documents,



labeling and training material.Accountable for QMS KPI execution results; monitor key performanceindicators and prepare progress reports for review meetings and senior management.Perform special assignments as directed.Job QualificationsBachelor's degree in engineering or a technical discipline.Minimum of 5 years of experience supporting or working within a medical device or other regulated industry.Minimum of 3 years of experience improving or maintaining a quality management system within the medical device or regulated industry.Minimum of 3 years in a leadership role managing a team.Experience with Canadian Medical Device requirements, U.S. FDA QSR, ISO 13485, ISO 14971, and Japanese Pharmaceutical Affairs Law (JPAL).Strategic thinker with strong leadership, organizational, problem‐solving, and decision‐making capabilities.Provides constructive feedback, coaching, and mentoring.Excellent interpersonal skills; able to work withdiverse cultures and management levels.Capable of building rapport, influencing without authority, and motivating teams without direct authority.Excellent verbal and written communication skills, including public speaking and facilitation.Proven success in driving and managing cultural change.Strong analytical, multitasking, time‐management,



and organizational skills with attention to detail.Works well under pressure in a fast‐paced environment and meets deadlines with accuracy.Understanding of business needs/requirements and system capabilities to develop effective solutions.Proficient with DMAIC / Black Belt / Six Sigma tools to analyze, drive root cause, and solve problems.Highly proficient in Microsoft Word, PowerPoint, Excel, Visio, and Project.Flexible working hours across multiple time zones for product‐related issues or global QMS projects.CompensationAnticipated starting base pay range for this full‐time position at this location is $97,957.00 to $132,241.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements).Artificial Intelligence is not being utilized in the Olympus hiring process.BenefitsEquitable OfferingsCompetitive salaries, annual bonusComprehensive medical benefits and pension planGenerous paid vacation and sick timePaid parental leave and adoption assistanceConnected CultureWork‐life integrated culture that supports an employee‐centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsEmployee Resource GroupsDedicated training resources and learning & development programsPaid educational assistanceEEO & Inclusion StatementIt is the policy of Olympus to extend equal employment and advancement prospect to all applicants and employees without regard to race, color, national origin, citizenship status, religion, 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, genetic information, ancestry, veteran status or any other characteristic protected by applicable federal, state or local law.#J-18808-Ljbffr

📌 Quality Manager Qms - Contract - C$97,957 - C$132,241 A Year (Richmond Hill)
🏢 OLYMPUS
📍 Richmond Hill