Shenzhen, CHN
3 days ago
Complain Handling (CH) and Vigilance Reporting Specialist
**Your role:** + 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. + Assess Risk assessment weather it is covering the hazard in the complaint + Complete all needed records in a timely & accurate manner + Confirming complaint condition & determining corrective action (including CAPA, FCO as required) + Collaborate with cross functional team such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers & Manufacturing personnel to facilitate the complaint handling process globally. + Evaluating & Investigating customer feedback, service records, and other sources of customer and internal for possible complaint. + Evaluating incoming data & determine if it is sufficient to understand the nature of the complaint **You're the right fit if:** + 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. + 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 + Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & Strong Analytical ability + Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment + Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies + Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment + Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams + Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have) **Personal Characteristics:** + Effective interpersonal, Communications & Excellent analytical skills + Self-starter, quick learner, ability to work independently, disciplined, and meticulous in work activities + Effective networking skills, detail oriented, ability to multitask through planning/organizing + Demonstrate Philips behaviors consistently + Excellent verbal, presentation, and written communication skills in Both Chinese and English + Drive self-initiative to improve process **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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