Director of Quality

Come join a team of highly skilled individuals who are dedicated to developing technology that will detect disease and save lives.

Breathe BioMedical is a medical technology company focused on developing an accurate breath test to detect early-stage breast cancer in women. Breath analytics involves the collection, processing, and analysis of breath samples to identify biomarker patterns associated with specific diseases. Breathe BioMedical is located in Moncton, New Brunswick and its US subsidiary is located in Boston, Massachusetts. One day, detecting disease will be as easy as breathing.

Position Title: Director of Quality

Location: Moncton, New Brunswick (On-site)

Term: Permanent; Full-Time

Hours of Work: 37.5 hours/week (Monday to Friday)

Summary: Breathe BioMedical is looking to hire a Director of Quality to maintain Breathe BioMedical’s ISO 13485 quality management system and oversee quality assurance activities associated to Breathe BioMedical’s regulated design, development and manufacturing activities.  The Director of Quality will also facilitate the development of quality control activities for processes both in and out of scope of Breathe BioMedical’s current quality management system, including expanding a quality management system to laboratory activities.   The Director of Quality will ensure Breathe BioMedical’s systems and processes remain in compliance with all applicable standards, regulations and comply with Breathe BioMedical’s quality and regulatory requirements, contributing to a culture of quality.

Qualifications

  • Bachelor’s degree in Science, Engineering, or equivalent.
  • Quality assurance credential considered an asset.
  • Progressive leadership experience with developing quality management systems, audit and IQ/OQ/PQ and process validation, with at least 5 years in a regulated industry.
  • Relevant quality assurance and quality control experience in the design and manufacture of medical devices.
  • Experience with the practical application of performance and other industry standards as they pertain to a variety of medical devices in risk and complexity.
  • 3+ years effectively managing and leading teams.
  • Experience working in a regulated laboratory environment considered an asset.

Key Responsibilities

  • Develop, document and maintain Breathe BioMedical’s quality management system and audits of data, policies, procedures and systems to ensure compliance with medical device (21 CFR 820) and ISO 13485, ISO 14971 and 21 CFR and other global regulations.
  • Assist in the implementation and maintenance of additional quality management systems for Breathe BioMedical’s laboratory facility (e.g., ISO 15189:2022 “Medical laboratories – requirements for quality and competence” or other equivalent quality standard).
  • Responsible for managing quality systems in successful implementation of highly technical or involved medical device development projects.
  • Manage corrective action teams and develop individual corrective action plans and systems.
  • Direct and manage the activities of quality assurance staff.
  • Establish systems to document and maintain compliance of process validation and drawing compliance.
  • Assist in performance management and career development of direct reports.
  • Analyze internal quality systems and associated data to assure adherence to QSRs, ISO and other international standards and corporate quality standards.
  • Develop, review and maintain quality policies in collaboration with corporate quality.
  • Responsible for the investigation of product and process quality manufacturing issues.
  • Develop quality control processes to identify and mitigate product nonconformities or issues that will impact quality or performance of product.
  • Participate in internal and external audits for the quality management system.
  • Develop, track and report on key quality metrics for processes in scope of the quality management system.
  • Keep the site and corporate leadership teams informed about quality related problems and issues.
  • Review quality audit reports and prepare appropriate corrective action responses.
  • Ensure compliance with GMP and ISO safety policies and good housekeeping and that safety and hazard practices are understood and followed.
  • Work to assure that quality assurance requirements are maintained.
  • Foster a collaborative and high-performance culture, ensuring individual and team goals aligned with the company’s vision and mission.
  • Execute other duties as may be required by the Executive Team, as training and experience allow.
  • Prioritize safety, quality, and compliance in all activities under the scope of the quality management system.

Competencies

  • Strong management and leadership skills along with strategic thinking ability, and a proven track record of success.
  • Strong leadership skills with the ability to inspire and motivate teams to achieve exceptional results.
  • Passionate about the company’s life-saving mission and committed to making a positive impact in healthcare.
  • Self-motivated with a high degree of initiative and sense of urgency.
  • Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handle multiple deadlines, in a hands-on environment.
  • Inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.
  • Solid decision-making skills.
  • Must work according to procedures, rules and regulations, with a passion for continuous improvement and quality.
  • Excellent communications skills (verbal, written, listening, conveying messages) with strategic thinking and negotiating strengths.
  • Ability to influence across peer group to ensure needs of on and off shift production requirements are met.                                        

Special Job Requirements and/or Training

  • New Employee Safety Orientation
  • Workplace First-Aid training; recertify as per training specifications
  • WHMIS training; recertify as per training specification
  • QMS: This position has roles and responsibilities associated to Breathe BioMedical’s QMS.  Please refer to Appendix B of Breathe BioMedical’s Quality Manual.  Required training will be provided in accordance with Breathe BioMedical’s Training Standard Operating Procedure (SOP) 6.2-1 Training and Qualification.

We offer competitive compensation, benefits and training and development. 

To apply send your resume to hr@breathebiomedical.com.  

We would like to thank all candidates for expressing interest. Only candidates legally entitled to work in Canada will be considered for this position.  Please note only those selected for interviews will be contacted.  Breathe BioMedical is an equal opportunity employer.