quality manager(medical imaging & ultrasound devices).

about the company

My client is a new start up medical company. They’re looking for a Quality System Manager to join their quality team. This role will be reporting to the GM.

about the job

• Develop, maintain, and optimize the Quality Management System (QMS) and eQMS, ensuring strict adherence to global medical device regulations including FDA 21 CFR Part 820, EU MDR, and ISO 13485
• Act as the Quality Management Representative for the Company
• Plan and execute annual Internal Audit to ensure all quality systems and procedures are effectively implemented and auditable at all times
• Participate in all new Projects, including giving inputs from quality perspectives, performing PFMEA etc
• Proper Quality Management System (QMS) in alignment with Integrated Management System (IMS) Guidelines and certifications
• Manage the certification strategy and audit framework relevant to the IMS
• Standardization of the QMS

job requirement

• Degree in quality / engineering or equivalent
• Min 8 years of experience in QMS for medical devices
• Demonstrated capability in executing production line testing, planning incoming inspections, utilizing electronic QMS platforms, and managing CAPA investigations
• Experience in a high volume manufacturing environment
• Prior experience with ultrasound medical devices will be a huge plus
• Experience managing contract manufacturers , sourcing them, establishing agreements, monitoring performance will be a plus
• Deep understanding and practical application of industry standards such as FDA 21 CFR Part 820, ISO 13485, IEC 60601-1, IEC 62304, Design Controls, and Risk Management
• Comfortable working around woodlands area

If you are interested in the position ...