JOB DESCRIPTION Job Title Complain Handling (CH) and Vigilance Reporting Specialist Job Description 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.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
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Complain Handling (ch) And Vigilance Reporting Specialist, Dongguan Shi
Free
Complain Handling (ch) And Vigilance Reporting Specialist, Dongguan Shi
China, Guangdong Sheng, Dongguan Shi,
发表 January 10, 2025
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Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2014 sales of EUR 21.4 billion and employs approximately 108,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.
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