Director of Quality Assurance

This Jobot Job is hosted by: Chris Gorman

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Salary: $185,000 - $215,000 per year

We are a Medical Device Manufacturing company that was founded with patient comfort in mind. Over 500 Million men worldwide suffer from enlarged prostate issues and many of them do not see effective relief from drugs, yet decline to undergo an invasive surgical procedure. Working in collaboration with the best urologists in the world, we made it our mission to come up with a new approach that is safer and more effective than any other option available. Our device is designed for a simple, atraumatic procedure in the urologist's office and ongoing clinical trials have shown positive results up to four years after treatment.

What We Offer:

• Competitive base salary and overall compensation package
• Full benefits: Medical, Dental, Vision
• Generous PTO, vacation, sick, and holidays
• Life Insurance coverage
• 401K

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. The successful candidate will be responsible for overseeing strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards and best practice including FDA QSR, ISO 13485, and EU MDD.

Responsibilities:

• Serves as Management Representative
• Hosts FDA and regulatory agencies’ quality system audits
• Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements
• Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13845, and MDD
• Writes quality objectives
• Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals
• Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements.
• Plans and manages internal audit activities and coordinates audit corrective actions
• Manages the quality group to ensure effective development and implementation of the Quality System Processes
• Performs other duties as assigned

Qualifications:

1. Bachelor's degree in Engineering, Quality Assurance, or related field. A Master's degree will be an added advantage.
2. Minimum of 10 years of experience in a Quality Assurance role in the manufacturing industry, preferably in the medical device sector.
3. Minimum of 5 years of supervisory experience. Excellent leadership and team management skills.
4. Proven experience with QSR, ISO 13485, EU MDD, and other international quality standards.
5. Extensive knowledge and experience with medical device and equipment manufacturing, a plus for experience with catheters, sterilization, and packaging processes.
6. Experience in preparing and submitting Premarket Approval (PMA) applications for Class III medical devices.
7. Strong knowledge of risk assessment and PFMEA processes.

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