Director Quality Assurance and Regulatory Compliance

POSITION SUMMARY:

The person in this position will provide overall company leadership and direction for the quality assurance and regulatory compliance function. Manage Quality Engineer(s), Document Control Specialist(s), and Quality Assurance Specialists and a Complaints group. Along with the VP the Director will ensure compliance with global medical device regulations.

DUTIES & RESPONSIBILITIES:

• Ensure adherence to internal procedures for cGMP production in accordance with EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.
• Manage the complaint handling and investigation function to ensure timely closure of complaints and metric reports per internal procedures.
• Hands on involvement in the medical device reporting system (eMDR).
• Serve as Deputy Management Representative, as needed, and coordinate presentation and lead management review discussions.
• Ensure design control elements are met at all stages of product development.
• Lead coordination of regulatory audits of Minerva’s Quality Management System.
• Manage the Corrective and Preventive Action process to guide the organization on the path of continuous improvement.
• Manage the Document Control function.
• Provide training in aspects of quality assurance, internal procedures and current Good Manufacturing Practices.
• Manage and lead the establishment and review of effectiveness of risk management activities.
• Ensuring external documents such as standards and regulations are kept up to date.
• Responsible for the selection, motivation and oversight of that staff for the achievement of the department’s goals

PREFERRED QUALIFICATIONS:

• ASQ certifications preferred e.g. Certified Quality Engineer, Certified Quality Auditor/Biomedical Auditor
• Excellent computer skills including but not limited to: Microsoft Office, Visio, Videoconferencing, EQMS
• Ability to work well under pressure, to handle multiple projects, and to meet aggressive deadlines.
• Ability to read and understand and implement to compliance regulations, standards and procedures.
• Ability to perform statistical analysis of data is required.
• Good leadership, analytical and interpersonal skills.
• High level of attention to details skills.
• High level of organization skills
• Effective verbal and written communication skills.
• Understanding of Medical Device Risk management.

Preferred Education and/or Job experience:

• Minimum of a bachelor’s degree, preferably in a scientific or technical field, as well as 8-10 years direct experience within the commercial medical device
• 10+ years quality engineering/assurance/control experience with Class III medical devices.
• 4+ years of hands on experience of leading a group of quality assurance individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
• Working knowledge of current EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.