Sr. Agile Quality Specialist, Lead

Resonetics, LLC; Montreal; On-site; CAD 100,000 - 140,000; Full time

Job summary

Resonetics, LLC in Montreal, QC, seeks a Senior Specialist, Quality, Team Lead to supervise the Quality R&D Engineering group and drive device development within the QMS framework. You will ensure regulatory compliance from concept through market introduction and coordinate audits with customers and regulatory bodies.

You will mentor engineers, manage resource planning, and collaborate with internal teams to meet timelines, budgets, and quality targets while promoting continuous improvement and

Qualifications

• Bachelor’s degree in engineering 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.

Responsibilities

• Provides direct supervision of Quality R&D Engineering team members and ensures resources are utilized to meet targets.
• Leads quality through device development, QMS and regulatory compliance with technical oversight.
• Coordinates project action items, tracks issues/risks, and ensures timely resource allocation.
• Serves as quality contact with external customers and coordinates audits and visits.
• Supports CAPA, complaints and nonconformity reports; fosters mentoring and career development.
• Supports internal and external audits and maintains alignment with procedures.

Skills

Quality leadership

Regulatory compliance

Project coordination

Problem-solving

Communication skills

French language

English language

Education

Bachelor's degree in engineering

Tools

MS Office

FMEA

Job description

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.