- Develop and maintain Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.).
- Establish and lead Quality team with the skills and abilities necessary to support the Quality Management System and the goals of the organization.
- Oversee the Quality Management System including complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration and control of nonconforming material.
- Lead Quality Engineers in the implementation of an effective product development process that complies with design control requirements.
- Establishes quality metrics monitoring, trending, response, and promotion to corrective actions as appropriate.
- Identify process improvement opportunities. Implement and develop processes and procedures that create the greatest value for the organization.
- Promote a culture of quality and continuous improvement throughout the organization.
- Partner effectively with Engineering and Manufacturing to ensure quality standards are being met.
- Ensure site readiness for external audits.
- Participate in inspections by regulatory agencies.
- Provides guidance across the organization to address compliance deficiencies.
- Duties, responsibilities and activities may change at any time with or without notice.
Working hours: Monday - Friday, 8:00AM - 5:00PM
--Bachelor's degree in Science or Engineering.
--Minimum of 5 years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical device or pharmaceutical industry.
--Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities, five or more years of management/leadership and development experience preferred.
--Working knowledge of FDA QSR, ISO, MDD, CMDCAS and/or other international quality systems requirements.
--Experience in QMS remediation and integration activities preferred.
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