Quality Compliance Specialist

Position Summary:

The Quality Compliance Specialist will oversee the Corrective and Preventive Actions process, ensuring regulatory compliance, timely resolution of quality issues, and continuous improvement of the Quality Management System (QMS). This role will maintain adherence to FDA, ISO 13485:2016, and other applicable regulations, while also providing training and creating management review records across both locations.

Key Responsibilities

· Maintain and support the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485:2016, and other applicable regulatory requirements.

· Manage and administer the CAPA process, ensuring timely initiation, tracking, investigation, root cause analysis, implementation of actions, and verification of effectiveness.

· Coordinate and facilitate CAPA meetings with cross-functional teams to review progress, address delays, and resolve issues.

· Collaborate with process owners and functional leads at each site to maintain consistency and alignment in CAPA documentation and execution.

· Monitor regulatory changes, ensure compliance with new and emerging requirements, and update QMS documentation accordingly.

· Develop and deliver training on new regulations to site personnel to ensure ongoing compliance readiness.

· Prepare and maintain monthly and quarterly Management Review records for both sites and oversee corporate-level Management Review activities.

· Act as the primary IT/Systems liaison for QA/RA related to the Quality Management System tool.

· Support internal and external audits, inspections, and investigations by providing accurate documentation and records.

· Perform additional quality compliance duties as required to support regulatory readiness and continuous improvement initiatives.

Qualifications:

· Bachelor's Degree in Engineering, Science, Business or an equivalent degree.

· 5 years minimum experience with 2-5 years of supervisory experience in a medical device company with quality assurance/document control experience in FDA/ISO regulated environment.

· Demonstrated understanding or aptitude to understand Medical Device Quality System regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

· Minimum 2 years Quality Assurance experience in the medical device or pharmaceutical industry.

· Demonstrated critical thinking, analytical, collaboration, negotiation & conflict resolution skills. Able to work cross-functionally with various groups.

· Organized and detail oriented; proven ability to meet deadlines.

· Ability to work independently in a fast-paced environment with little supervision.

· Open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations.

· Accept and adhere to high ethical, moral and personal values in decisions, communications and when dealing with others.

· Ability to accept constructive criticism and deal calmly and effectively with high-stress situations.

· Reliable, responsible, dedicated and committed to fulfil obligations.

· Strong communication, analytical, organizational and management skills

· Proficiency with Agile, SharePoint, On Base, MS Office, MS Project, Visio and electronic document management systems.

· Strong team-building skills, with the ability to function as a team player or leader in cross-functional teams to obtain necessary results.

· Conscientious and is attentive to detail, balanced with big-picture thinking.

· Experienced with authoring and maintaining procedures and work instructions.

· Knowledge of compliance, related to all applicable Quality Systems Standards national and international.

· The ability to evaluate and communicate compliance needs.

An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet

Company DescriptionMotion Concepts is a leading Canadian manufacturer of complex rehabilitation seating and mobility solutions, serving clients across North America. We design, engineer, and build highly customized power-chair seating systems with a focus on quality, safety, and innovation. Our team works closely with clinicians and distributors to deliver products that improve comfort, independence, and quality of life for individuals with mobility challenges.Company DescriptionMotion Concepts is a leading Canadian manufacturer of complex rehabilitation seating and mobility solutions, serving clients across North America. We design, engineer, and build highly customized power-chair seating systems with a focus on quality, safety, and innovation. Our team works closely with clinicians and distributors to deliver products that improve comfort, independence, and quality of life for individuals with mobility challenges.