Baylis Medical Technologies · Mississauga, ON, Canada
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The Big Picture
The Manager, Quality Assurance and Excellence is responsible for the administration and direct supervision of the Quality Assurance and Excellence Team. They are responsible for the continued effectiveness, compliance, measurement, analysis and improvement of the quality management system at Baylis Medical Technologies, including Document Control, Training, CAPA, Complaints, Internal Audit, Recalls, standards compliance and continuous improvement activities.
Impact Through Innovation
Technical Duties:
Leads the execution, maintenance and continuous improvement of quality systems, policies and objectives, ensuring alignment with regulatory requirements and company goals.
Establishes and sustains a highly effective CAPA process, ensuring disciplined adherence to procedures and timely completion of investigations, root cause determination, implementation and effectiveness activities.
Partners with CAPA and investigation owners to ensure records are risk-based, technically sound, adequately documented and completed within committed timelines.
Oversees quality assurance and excellence functions, including Document Control, Training, CAPA, Complaints, Internal Audits, Recalls and Field Actions, standards compliance, as applicable.
Enforces compliance with regulatory requirements through supporting internal, supplier and external audit activities and supports regulatory and certification-body inspections.
Coordinates, analyzes and reports Quality Management System key performance indicators to identify trends, risks, recurring issues and improvement opportunities.
Undertakes independent studies, analyses, interpretations and conclusions to assess compliance with new or revised standards and regulations.
Ensures Quality Management System training is current, effective and appropriate for assigned responsibilities.
Coordinates and leads significant investigations and escalations, including customer performance issues, and interfaces with Engineering and Production on quality-system matters.
Facilitates the customer complaint process to support timely investigation, trending, escalation and global regulatory compliance.
Leads quality excellence projects and continuous improvement initiatives to improve operational efficiency, product quality and Quality Management System effectiveness.
Promotes a culture of quality and partners with Operations, Supply Chain, Manufacturing, Regulatory, R&D, Sales and other functions to implement sustainable improvements.
Decision-making Authority:
Work is assigned in terms of broad objectives and is reviewed for soundness of approach and general effectiveness.
Makes independent, risk-based decisions on work methods, priorities and procedures required to achieve quality and business objectives.
Determines or delegates Quality Assurance approval authority based on competency, risk and procedural requirements.
Provides compliance direction and escalates significant product, customer or regulatory risks when appropriate.
Planning Responsibility:
Conducts planning for the Quality Assurance and Excellence group using mature quality assurance knowledge and input from appropriate stakeholders.
Participates in short- and long-range department planning, including review of resources and budgets required to perform quality functions.
Sets group goals and objectives, establishes quality excellence priorities and tracks key performance indicators to measure progress.
Leads project planning and implementation of Quality Management System updates and continuous improvement initiatives.
Leadership Authority/Supervision Exercised:
Provides technical and department-level leadership to Quality Assurance and Excellence staff.
Assigns and reviews work, advises on complex problems and confirms work is accurate and adequate to meet compliance requirements.
Provides direct and sustained supervision to professional staff and ensures the team is adequately resourced and competent.
Responsible for coaching, performance evaluation, career development and succession planning for the Quality Assurance and Excellence group.
Makes recommendations concerning selection, training, evaluation, recognition, remuneration and discipline of staff.
Conducts routine administrative management activities, including approval of vacation requests within delegated authority.
Your Unique Expertise
Minimum Bachelor’s degree in Engineering, Science or a related technical discipline
Minimum of 8 years’ progressive experience in Quality Assurance, Quality Systems or Quality Excellence
Minimum of 5 years’ experience in the medical device industry or an equivalent regulated industry
Minimum of 5 years’ experience in a manufacturing environment
Minimum of 2 years’ experience leading and coaching others. Demonstrated ability to assess, develop, motivate and empower professional staff
Working knowledge of and experience with U.S. FDA quality system requirements, ISO 13485, ISO 14971, ISO 19011, Canadian Medical Devices Regulations, EU medical device requirements and other relevant jurisdictional regulations
Demonstrated experience leading audits and supporting customer, certification-body and regulatory inspections with successful outcomes
Demonstrated skills in achieving results and managing others to achieve objectives
Demonstrated experience making risk-based decisions to resolve complex problems and providing sound compliance advice and direction
Demonstrated successful interdisciplinary collaboration and ability to promote a culture of quality
Strong expertise in statistical and analytical techniques, quality metrics and continuous improvement methods. Ability to write clear technical documentation, correspondence, procedures and workflows
Strong interpersonal, communication, presentation, negotiation and conflict-management skills
Demonstrated proficiency in project mana…
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University of Waterloo · 11-50 employees · since 2021
Baylis Medical Technologies · Mississauga
