Your role:

61 Analyzing complaint data, gathering additional data, as needed, and partnering cross functionally to share feedback to the development & manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints.
61 Assess Risk assessment weather it is covering the hazard in the complaint
61 Complete all needed records in a timely & accurate manner
61 Confirming complaint condition & determining corrective action (including CAPA, FCO as required)
61 Collaborate with cross functional team such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers & Manufacturing personnel to facilitate the complaint handling process globally.
61 Evaluating & Investigating customer feedback, service records, and other sources of customer and internal for possible complaint.
61 Evaluating incoming data & determine if it is sufficient to understand the nature of the complaint

You’re the right fit if:

61 Bachelor’s / Master’s degree in mechanical engineering, Bio Medical, Healthcare, Application Engineer, Nursing, or related technical degree with over 6 years (Medical device preferred) of experience.
61 Hands on experience of Customer complaining experience in Medical industry is required, CAPA, Field Corrections as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820
61 Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & Strong Analytical ability
61 Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment
61 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies
61 Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment
61 Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams
61 Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have)