Sr. Agile Quality Specialist, Lead

Job summary

Leads and supervises Quality R&D Engineering team members, providing technical direction and ensuring quality and regulatory compliance throughout medical device development. Coordinates project deliverables, resources, risks, customer quality communications, audits, and corrective and preventive actions while supporting team development.

Job details

Overview Reporting to the Senior Quality Manager, this member of the Quality team will provide direct supervision of the Quality R&D Engineering team members. The Senior Specialist, Quality, Team Lead at Agile MV Technologies Inc (a Resonetics company) will be responsible for supporting company quality and regulatory compliance of medical device development from concept through market introduction. Will impart knowledge and experience, provide technical direction, support project documentation content review, support and assist product development project teams in accordance with all applicable procedures. Also, will manage effective QA resource planning and prepare report status updates on a regular basis. This position is required to communicate with the customer or customer quality representative on occasion to provide the requested assistance. Responsibilities Provides direct supervision of Quality R&D Engineering team members. • Ensures that direct reports are efficiently utilized and meets billable targets. • Leads Quality team through device development, QMS and regulatory compliance. • Provide technical oversight. • Sets direction on core quality objectives. • Coordinates project action items. Manages and assign tasks among team members to drive execution of project deliverables. • Collaborate with internal departments to keep on track of project progress against originally proposed timeline, scope, and budget; communicates and documents changes as needed. • Understands, tracks and articulates issues / risks / action items; coordinates with management to ensure that appropriate resources have been assigned and works with responsible task owners to address action items on a timely basis. • Compile and monitor indicators. • Serves as quality contact with external customers. Coordinates customer visits, and audit communications when requested. • Fosters career development of direct reports, mentoring and coaching as appropriate. • Actively support internal and external audits. • Support the corrective and preventive actions, complaints and nonconformity reports. • To maximize the effectiveness of the position, this job description is subject to change according to a consensus of the 2 parties (Agile MV Technologies Inc «A Resonetics Company» and the employee). Required Qualifications Bachelor’s degree in engineering, certification or equivalent experience. - Minimum 5 years in the quality management system. - Minimum 5 years in Medical Device Design and Development. - Strong ISO 13485 and Regulatory compliance. - Design and Development documentation requirements (FMEA - Special Processes). - Good knowledge of Microsoft Office tools (Word, Excel, Visio, PowerPoint, Outlook) - Strong Problem-Solving tools (Brainstorming, Ishikawa, Pareto) - Knowledge of 6 sigma approach, an asset. - Management and mentoring skills. - Excellent Organizational skills. - Dynamic. - Passionate about problem-solving, innovation and creativity. - Advanced level of oral and written French. - Advanced level of English, to interact with customers and suppliers who are mainly international. To comply with international industry standards.

What you’ll do

Leads and supervises Quality R&D Engineering team members, providing technical direction and ensuring quality and regulatory compliance throughout medical device development. Coordinates project deliverables, resources, risks, customer quality communications, audits, and corrective and preventive actions while supporting team development.

Requirements

Requires a bachelor's degree in engineering, certification, or equivalent experience, with at least five years in quality management systems and medical device design and development. Candidates should have strong ISO 13485 and regulatory compliance knowledge, design documentation experience, problem-solving skills, management and mentoring abilities, and advanced French and English proficiency.

Listed skills

• Regulatory Compliance · Preferred
• Problem solving · Preferred
• Team Leadership · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Management Systems
• Medical Device Design and Development
• ISO 13485
• Regulatory Compliance
• Design and Development Documentation
• Failure Mode and Effects Analysis
• Special Processes
• Problem-Solving
• Brainstorming
• Ishikawa Diagrams
• Pareto Analysis
• Six Sigma
• Team Leadership
• Mentoring and Coaching
• Resource Planning
• Audit Support
• Project Documentation
• Industry Standards
• Organizational Skills
• Medical Device Development
• Microsoft Excel
• Six Sigma Methodology
• Agile Methodology
• Asset Management
• Auditing
• Management
• Corrective And Preventive Action (CAPA)
• Communication
• Creativity
• English Language
• External Auditing
• Failure Mode And Effects Analysis
• French Language
• Innovation
• Internal Auditing
• ISO 13485 Standard
• Problem Solving
• Mentorship
• Microsoft Outlook
• Microsoft Office
• Microsoft Visio
• New Product Development
• Microsoft PowerPoint
• Project Coordination
• Quality Management
• Coaching
• Safety Assurance

Job areas

• Engineering
• Management & Leadership
• Healthcare
• Manufacturing
• Service Quality Specialist
• Quality Engineering Manager
• Manufacturing Managers
• Architectural and Engineering Managers