Quality/ QA Associate Manager (US Medical Devices Manufacturing MNC)

Job description

Responsibilities:

• Manage and/or lead a small team within the Training and Document Control function to ensure all documents and procedures are properly implemented, maintained and archived.
• Ensure implemented training and document control processes continuously meet company’s Quality System in compliance with regulatory requirements (FDA, ISO13485)
• Lead special projects (e.g. Training/documentation remediation) in collaboration with team members; identify opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancements with the accountability for successful completion of assigned deliverables
• SME for Training & Change Control System, including leading the implementation of any new system and training requirements.
• Provide training on LMS & Change Control System to employees across functions to ensure appropriate utilization of the system
• Review and analyse metric reports to assess and determine effectiveness of implemented training and Document Control systems

Requirements:

• Bachelor's Degree or Equivalent in Engineering or Science with 8 years of working experience within medical device or pharmaceutical industry
• Extensive knowledge with US Quality Systems Regulation (21 CFR Part 820) and ISO13485:2016 Quality Management System is highly desirable
• Hands-on experience in Training and Document Control function in class II/III medical devices
• Experience with project management and project management software tools preferred
• Demonstrated ability to supervise teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Excellent verbal and written English communication skills
• Strong interpersonal skills are required
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to process complex situation, “grey areas”, and work well under pressure
• Able to lead and manage multiple tasks in a timely manner
• Must be able to work with cross-functional teams as well as with colleagues from other departments within assigned area
• Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment

Please contact Angel Fu at +65 6950 0358 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion.

EA License no: 16S8066 | Registration no: R1983939

Only successful candidates will be notified.