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About the Role
Thoughtfully and strategically help refine and implement our Quality Management System and support regulatory submissions such as ISO 13485 MDSAP to Health Canada, and 510K to FDA. Some common tasks provided below.
Roles and responsibilities
• Review standard operating procedures (SOPs), Master Batch Records, Standard Test Methods, and other controlled documents for compliance with regulations and propose changes for review and approval
• Responsible for QA activities associated with validation and production of AIDREA and the panel of software; these include review of non-conformance reporting and investigations, follow up with CAPAs and change control activities
• Review and approval of specifications for incoming raw materials and for finished products
• Review validation and stability protocols for compliance
• Review reports for compliance with protocols, quality system and regulatory requirements
• Support validation activities including review of executed batch records and testing data, for compliance, including OOS, non-conformances, Change Controls and CAPAs
• Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality and use this knowledge to improve the quality system; participate in building the Quality Management System according to Health Canada and FDA regulations, 21 CFR part 820 AIMD and ISO 13485 MDSAP guidance
• Support maintenance and improvement of the Quality Systems
• Represent Quality Assurance on project teams
• Assist in drafting and finalizing Annual Product Quality Reviews
• Assist in carrying out internal quality audits on company systems and documentations
• Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines
• Assist in the maintenance of Quality Management System under direction of Director, Quality Assurance
• Responsible for planning, implementing, and managing compliance of manufacturing and production processes.
• Develop and deliver department requirements for quality engineers (line support and customer complaint investigations) and quality technicians.
• Support by providing QA oversight to operations, customer complaints and service.
• Ensure product containment of manufacturing non-conformances, to include immediate corrective activities as appropriate and the determination of systemic corrective and preventive actions.
• Leadership of customer complaint investigations.
• Ownership of QA operations quality metrics.
• Manage the device history record process including localized document control activities.
• Lead improvement activities involving Quality processes.
• Complete any other related duties that support the core activities and mission of the Centre, as required
Requirements
Bachelor’s degree required. Degree in a related engineering, medical, science or regulatory discipline strongly preferred.
3+ years in the medical device industry or related GMP environment or equivalent preferred.
2+ years of experience leading direct reports.
Thorough knowledge and understanding of medical device regulations and standards, including but not limited to ISO 13485 MDSAP, QSR, CMDR, Medical Device Directive and the EU Medical Device Regulation.
Experience in the ISO Quality System and other applicable industry requirements is required.
Experience in supporting internal/external audits (ISO audits, Customer audits, Electrical Safety audits, FDA inspections).
Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills.
Strong leadership and influencing skills.
Must have the ability to make effective presentations to all levels of the organization.
The proven ability to prioritize and manage multiple projects and meet deadlines is required.
Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
Experience building a high-performance team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
Experience working with diverse cultures and employees.
Strong knowledge of tools and techniques for failure investigations.
Successful track record for identifying and implementing systemic corrective and preventive actions.
Successful track record for leading improvement activities.
Knowledge and experience with Lean methods sufficient to achieve and sustain substantial improvements.
Knowledge of equipment, process, and software validation requirements.
Knowledge in IPC standards (IPC A 610, IPC/WHMA-A-620) will be a plus.
Knowledge in Python, Pytorch or other coding languages is a plus.
Prior experience working in an FDA-regulated environment in medical devices is a plus.
ASQ Certifications for Quality Engineering or Certified Manager of Quality/Organizational Excellence is desirable.
Occasional (<5%) travel may be required based on business need.
Advanced Microsoft Office skills including Word, Outlook, Excel, Visio and PowerPoint.