Breathebiomedical
Director of Quality
Breathebiomedical, Oklahoma City, Oklahoma, United States,
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. One day, detecting disease will be as easy as breathing.Position Title:
Director of QualityTerm:
Permanent; Full-TimeHours 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 with Breathe BioMedical’s regulated design, development, and manufacturing activities. The Director of Quality will ensure Breathe BioMedical’s systems and processes remain in compliance with all applicable standards, regulations, and quality requirements, contributing to a culture of quality.QualificationsBachelor’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.Key ResponsibilitiesDevelop, 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.Manage corrective action teams and develop individual corrective action plans and systems.Direct and manage the activities of quality assurance staff.Analyze internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards and corporate quality standards.Participate in internal and external audits for the quality management system.Ensure compliance with GMP and ISO safety policies and good housekeeping.Foster a collaborative and high-performance culture, ensuring individual and team goals align with the company’s vision and mission.Special Job Requirements and/or TrainingNew Employee Safety OrientationWorkplace First-Aid training; recertify as per training specificationsWHMIS training; recertify as per training specificationWe offer competitive compensation, benefits, and training and development.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.
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Breathe BioMedical
is a medical technology company focused on developing an accurate breath test to detect early-stage breast cancer in women. One day, detecting disease will be as easy as breathing.Position Title:
Director of QualityTerm:
Permanent; Full-TimeHours 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 with Breathe BioMedical’s regulated design, development, and manufacturing activities. The Director of Quality will ensure Breathe BioMedical’s systems and processes remain in compliance with all applicable standards, regulations, and quality requirements, contributing to a culture of quality.QualificationsBachelor’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.Key ResponsibilitiesDevelop, 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.Manage corrective action teams and develop individual corrective action plans and systems.Direct and manage the activities of quality assurance staff.Analyze internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards and corporate quality standards.Participate in internal and external audits for the quality management system.Ensure compliance with GMP and ISO safety policies and good housekeeping.Foster a collaborative and high-performance culture, ensuring individual and team goals align with the company’s vision and mission.Special Job Requirements and/or TrainingNew Employee Safety OrientationWorkplace First-Aid training; recertify as per training specificationsWHMIS training; recertify as per training specificationWe offer competitive compensation, benefits, and training and development.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.
#J-18808-Ljbffr