Epineuron is a pioneering nerve care company. We specialize in the creation of bioelectronic solutions, aiming to revolutionize the repair and treatment of damaged nerves. Our flagship technology, the PeriPulse™ Nerve Stimulation System, uses electrical stimulation to harness the regenerative potential of peripheral nerves, accelerating their recovery after injury. Its design offers surgeons a seamless clinical workflow by enabling direct nerve stimulation outside of the operating room, in the recovery room. PeriPulse™ is Health Canada approved and designated as an FDA breakthrough device.

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Job Description

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As the Quality Manager you will play a crucial role in the design and manufacturing of Epineuron’s medical devices.

You will be responsible for managing an MDSAP certified Quality Management System (QMS), as well as leading a team of quality and engineering professionals to maintain compliance with applicable standards, regulatory requirements, and industry best practices. In addition, you will oversee medical device manufacturing processes, be involved in the Design and Development Process, assist Risk Management Activities, and lead CAPA efforts to identify opportunities for improvement of the company’s processes and product quality. This role requires a strong commitment to advocate for quality, attention to detail, and the ability to work collaboratively with cross-functional teams. The person will report directly to company management and provide strategic insight to help achieve the mission of the company.

Epineuron is located in Mississauga, Ontario. Position is on-site.

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Responsibilities

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Quality Management System (QMS):

• Develop, implement, and maintain an effective QMS that complies with ISO 13485 and applicable regulations and standards.

• Continuously improve the QMS to enhance product quality, efficiency, and regulatory compliance.

• Maintain accurate and up-to-date quality documentation, including quality manuals, procedures, and records.

• Lead and manage all QMS processes, including Management Reviews, Internal Audits, CAPAs, Non-conformance Handling, Change Control, Feedback & Complaints, Reporting, etc.

• Generate and present quality reports to management as required.

• Act as Management Representative for notified body audits.

• Prepare, support, and represent company for regulatory body audits and inspections.

• Establish and enforce quality control procedures for the company’s manufacturing processes.

• Collaborate with cross-functional teams to identify and resolve quality issues and non-conformities.

• Conduct supplier audits and establish Quality Agreements to ensure suppliers meet the company’s QMS requirements.

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Engineering / Research & Development:

• Represent Quality Assurance within a cross-functional engineering team.

• Support the implementation of Design Control for the company’s design and development projects, throughout the entire medical device commercialization process.

• Draft and support the development of Quality Plans and Project Tracking Plans for projects.

• Develop, review and approve design history files (e.g., requirements, risk management, usability files, verification and validation plans, protocols, and reports).

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Team Leadership:

• Provide technical, project level leadership to engineering assistants or junior engineering staff, providing guidance and support in their roles.

• Foster a collaborative and accountable work environment within the company.

Qualifications

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• Engineering bachelor’s degree

• Minimum 5 years of Quality Systems management experience within the medical device industry.

• Excellent written and verbal communication skills.

• Experience in supervisory and managerial positions.

• Organized, attentive to detail and able to prioritize and handle multiple projects with competing deadlines.

• Certificates for ISO 13485:2016 internal auditor training and/or MDSAP overview

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Why you’ll love working at Epineuron: 

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• We’re a small team committed in our mission to profoundly impact patients’ lives

• Everyone’s contribution is valued and held to a high-performance standard

• We have a friendly, open, and fun team culture that values unique perspectives 

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Epineuron is an equal opportunity employer. We are committed to providing a diverse and inclusive work environment, while providing ongoing education for all employees. Qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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Please inform us if you require any accommodations during the recruitment process. While we thank all applicants, only those being considered for an interview will be contacted.

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Anticipated Start Date: Immediate

Schedule: Full time (Monday to Friday at 8 hours per day or 40 hours per week). Occasional travel (<10% of time).

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Compensation commensurate with experience.

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Please submit a resume/CV as a PDF.

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