Merrithew is the global leader in mind-body education and equipment. Founded in 1988, the company has trained more than 80,000 instructors and partners worldwide, developed six innovative education programs-- STOTT PILATES, ZENGA, Total Barre, Halo Training, Merrithew Fascial Movement and CORE(TM) Athletic Conditioning & Performance Training(TM)-- and has produced an extensive line of professional and at-home equipment and accessories for personal and professional use.
Join Merrithew in its mission to inspire people worldwide to lead healthier lives through premium education programs and cutting-edge equipment. With a focus on world-class education and industry-leading equipment, Merrithew is dedicated to promoting optimal fitness and wellness for all.
Position Overview:
The Quality Engineer is responsible for supporting the organization's QMS, ensuring product and process compliance with regulatory, customer and internal requirements. The role will drive continuous improvement initiatives, manage quality documentation and oversee a team of quality inspectors.This role will focus on supporting new product launches, ensuring quality is built into every stage--from design to validation to production release. The successful candidate will bring strong problem-solving, leadership, and technical skills to help elevate product and process performance.
Major Responsibilities:
Lead Quality activities related to new product launches - including specification review, inspection plan creation, validation planning and qualification of products.
Supervise and provide daily direction to Quality Inspectors.
Provide training on inspection techniques, documentation and compliance requirements within the organization.
Maintain, identify gaps and continuously improve the Quality Management System (QMS).
Ensure compliance with CE, Medical Devices requirements and other relevant regulations.
Lead Internal investigations of nonconformances, customer complaints and process deviations. Ensuring effective root cause analysis and CAPA implementation.
Support Supplier Quality Management by investigating SCARs, verifying corrective actions, and evaluating supplier capabilities.
Support and conduct internal and external audits as required.
Maintain document control program. Develop and update Quality Procedures, Work instructions, Forms, Checklists, etc.
Own and plan for product inspection at various stages of production cycle, including incoming inspection, in-process and final inspection. Monitor and analyze inspection results and act accordingly.
Own change management (ECR/ ECN) process, ensure change requests and notices are reviewed, approved and closed on time with proper evidence and documentation. Lead product qualification and validation activities.
Perform Risk Analysis and develop control plans.
Participate in lean and process improvements initiatives to reduce defects and improve yield.
Other duties as assigned.
Skills and Qualifications:
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Post-Secondary education in Engineering, Quality or a related technical field.
5+
years' experience in Quality Assurance Engineering in a manufacturing environment, preferably in a medical device field.
In depth understanding of a Quality Management System and requirements of ISO 9001, ISO 13485, and preferably EU Medical Devices Regulations.
Proven track record in New Product Launches, such as APQP or Stage Gate.
Proficiency in quality tools and methodologies such as FMEA, 8D, Lean Manufacturing.
Proven experience in leading internal investigations and managing SCARS with suppliers.
Proficiency in understanding technical drawings, specifications and GD&T.
Proficient in Microsoft Office, including Word, Excel, Power Point.
Quality certification is considered an asset (e.g. Lean and Six Sigma Green Belt, CQE, QMS Auditor)
Excellent time and project management skills with a high attention to detail.
A team player with excellent communication and leadership skills.
Merrithew is committed to providing accessible employment practices that comply with the Accessibility for Ontarians with Disabilities Act (AODA).
Merrithew is committed to providing a barrier-free access workplace. If you need accommodation at any stage of your application, or want more information on our accommodation policies, please contact us "careers@merrithew.com"
Merrithew is proud to be an Equal Opportunity Employer. Our organization respects and follows the letter and spirit of the Ontario Human Rights Code. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or any other code grounds.
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