Quality Systems & Compliance Manager

Intuvie has a track record of bringing impactful innovations to the healthcare industry – namely in the area of infusion therapies. We provide both large volume and ambulatory infusion pumps, as well as connectivity software that improves clinician productivity. At Intuvie, our mission is to deliver both simplicity and control of infusions through ease of use, portability, affordability, and safety-driven designs that can be used by patients and clinicians alike.

Quality Systems & Compliance Manager

Ensure full compliance with 21 CFR 820, 21 CFR 807, 21 CFR 803, ISO 14791, FDA Guidelines for Infusion Pumps, CAPA, Risk Management, and other relevant FDA, ISO, ICH, and Industry Standards and Guidelines.

The Key Responsibilities:

The Quality Systems and Compliance Manager is responsible and accountable for compliance with US FDA regulatory requirements, as well as company procedures and policies. This position is a key interface between all functions within Intuvie Holdings which execute activities pertaining to 21 CFR Parts 820 and 803.

Areas of specific responsibility include:

Developing, implementing, and maintaining the Intuvie Quality Manual and Quality Management System (QMS).

Ensuring all Intuvie QMS Element SOPs comply with applicable Regulations.

Managing the Document Control QMS Element including an electronic Document Management system and compliance with FDA requirements and the Intuvie Record Retention Policy.

Managing the CAPA program.

Manage the Quality Engineering function ensuring the use of proper tools and process for administration of the QMS.

Managing the Internal Audit Program to prevent unfavourable FDA Inspection outcomes.

Managing a team with responsibility for execution of the QMS.

Managing key aspects of the Front Room during FDA Inspections and third-party audits such as the documents requested/reviewed log and daily transcripts. Leading the Back Room during FDA Inspections and third-party audits.

Leading the Escalation to Management Process; developing slide decks/overviews, and meeting minutes for Escalation to Management and Quality Review Board Meetings.

Creating and presenting metrics for quarterly Quality Management Review Meetings; maintaining Quality Management Review slide decks and preparing Quality Management Review Meeting minutes.

Managing the GMP Training QMS Element and associated IT Tool(s) used for training curriculum and training records.

Leading Field Action Tactical Team(s).

Conducting GMP training for all employees annually.

Maintaining a strong collaborative partnership with cross-functional team members to facilitate a favourable compliance profile, protecting patient/user safety, compliance with all applicable Regulations, and meeting business needs.

Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Key Capabilities Required:

Quality Management System Protégé’ or Mastery level knowledge and expertise

Product Knowledge Student or Protégé level knowledge and expertise

First-hand knowledge of Infusion Pump Technology and Software as a Medical Device. (Student level capable of learning)

General Quality Assurance and Quality System Protégé or Mastery level knowledge and expertise

Qualifications:

BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.

Seasoned Quality professional/leader with 5-8 years of experience, including people management, in the medical device industry; preferably in developing and maintaining Quality Management Systems for Class II or III medical devices.

Demonstrated applied knowledge of regulatory requirements for Medical Devices (ISO 14971 and 21 CFR 820 at a minimum).

Demonstrated leadership experience through formal and informal assignments.

Results orientated, multi-tasker, and quick learner; understands and respond to urgency.

Able to successfully manage workload to timelines.

Excellent verbal, written, and interpersonal skills.

Applied knowledge of Microsoft Office software including Excel, Word, and PowerPoint