Medical Device Quality Assurance Director

23 hours ago


South San Francisco, California, United States Jobot Full time
Job Title: Director of Quality Assurance

About the Role:
Jobot is seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring the highest level of quality in our products.

Key Responsibilities:
Oversee strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards, and best practices.
Serve as Management Representative and host FDA and regulatory agencies' quality system audits.
Set up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements.
Routinely evaluate the existing quality system to identify opportunities to streamline processes and ensure compliance with FDA QSR, ISO 13485, and MDD.
Write quality objectives and manage quality resources, including personnel, equipment, and budget in alignment with departmental and corporate goals.
Perform Management Reviews and advise management of any product or process-related issues and make recommendations for improvements.
Plan and manage internal audit activities and coordinate audit corrective actions.
Manage the quality group to ensure effective development and implementation of the Quality System Processes.

Requirements:
Bachelor's degree in Engineering, Quality Assurance, or related field.
Minimum of 10 years of experience in a Quality Assurance leadership role in the manufacturing industry, preferably in the medical device sector.
Excellent leadership and team management skills.
Proven experience with QSR, ISO 13485, EU MDD, and other international quality standards.
Extensive knowledge and experience with medical device and equipment manufacturing, including catheter manufacturing, sterilization, and packaging processes.
Experience in preparing and submitting Premarket Approval (PMA) applications for Class III medical devices.
Strong knowledge of risk assessment and PFMEA processes.

About Jobot:
Jobot is a Medical Device Manufacturing company that was founded with patient comfort in mind. We are seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring the highest level of quality in our products.

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