| Associate Director, Quality Assurance :: Raleigh, NC onsite at Raleigh, North Carolina, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2619119&uid=3282b04c806e40479e614404552915d6 From: Praveen Nagar, Vyze inc [email protected] Reply to: [email protected] Job Description - Note : Need best candidate with DL, VISA AND LINKEDIN. Position: Associate Director, Quality Assurance Location: Raleigh, NC (3 days/week onsite at 6501 Six Forks Rd.) Duration: 08/15/2025 11/15/2025 Reporting To: Global R&D Quality Leadership Travel: Up to 15% (local, national, or international) Onsite Requirements: Yes, 3 days/week Must Have Skills 7-8 years of quality experience in medical device development Bachelors degree in Engineering or Life/Health Sciences Direct experience with Class II medical devices and 510(k) submissions Strong working knowledge of: 21CFR 820, ISO 13485, ISO 14971 Experience with GMP and Design Control for medical devices Experience overseeing/leading R&D quality activities across the full device development lifecycle Leadership/management experience (performance management, mentoring, coaching for global teams) Hands-on risk management experience (developing/overseeing risk plans, reports, risk files) Experience with human factors/usability in device development Experience with audits (internal, supplier/vendor, regulatory authority) Strong written and verbal communication skills Demonstrated ability to manage multiple projects, independently prioritize, and deliver on tight deadlines Proficiency in MS Office Suite Eligible to work in the US and available for 3 days/week onsite in Raleigh Preferred Skills Masters degree in a related field ASQ Certified Quality Engineer or equivalent certification Experience with Energy-Based Devices Experience with IEC 60601-1 and IEC 62304 Experience using Quality Management Software Global/matrix organization experience Job Description The Associate Director, Quality Assurance provides strategic management and oversight for R&D Quality activities related to GMP for non-Energy Based Devices (EBD) and EBD Medical Devices. This includes staff management, performance management, and ensuring that all R&D quality operations are aligned globally and compliant with relevant regulatory standards. Youll oversee design control, specification development, risk management, human factors/usability, manufacturing transfer, document reviews, regulatory submissions, and all audit activities. Key responsibilities include: Managing and developing a global R&D Quality team Overseeing and improving R&D quality processes and ensuring compliance throughout the device development lifecycle Leading teams through design control and maintaining design history files Overseeing risk management and human factors/usability processes Coordinating and supporting internal, supplier, and regulatory audits Maintaining up-to-date knowledge on regulations and ensuring policies are current Supporting departmental SOPs, CAPAs, deviations, change requests, and corporate initiatives Facilitating R&D quality improvements and harmonization projects Communicating effectively across functions and with executive leadership Supporting R&D projects as needed and performing other duties as assigned The role is Monday to Friday, 8-5, and requires 3 days per week in the Raleigh office Keywords: rlang microsoft North Carolina Associate Director, Quality Assurance :: Raleigh, NC onsite [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2619119&uid=3282b04c806e40479e614404552915d6 |
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| 01:57 AM 24-Jul-25 |