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Director of Quality

3 weeks ago

Moncton, Canada Breathe BioMedical Full time

**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.

**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.
- 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, priorit