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Customer Advocate - Complaint Specialist

8.00 to 10.00 Years   Pune   03 Feb, 2021
Philips
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

null#LI-PHILINJob DescriptionJob Title - Customer Advocate - Complaint SpecialistJob Location - Pune ChakanKEY AREAS OF RESPONSIBILITIES:

  • Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint investigation. Evaluate customer feedback and customer and internal data for possible complaints.
  • Frequently interacts with subordinate supervisors and/or functional peer group managers, normally involving matters between functional areas within the Business unit. Often must lead a co-operative effort among members of a project team.
  • Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
  • Manages operational activities for the Complaint Handling Unit (for e.g. daily management, development and administration of schedules)
  • Support all external domestic and international inspections and audits as well as internal audits when required by CHU Management.
  • Lead ongoing improvement initiatives in the complaint handling process.
  • Support CHU Management in maintaining complaint handling procedures and work instructions.
  • Liaise with the Vigilance Reporting team for critical complaints (for e.g. initial assessment of reportability) and any request of information from Competent Authorities and Notified Body.
  • Assess if the Risk assessment is covering the hazard in the complaint.
  • Confirm complaint investigation and determine corrective action is needed as per applicable procedures (e.g. CAPA).
  • Review complaint records of other complaint investigators to warrant the quality of the complaint record.
  • Analyze complaint data, gather additional data as needed, and partner cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolve complaints.
  • Ensure complaint handling target metrics are met on a routine basis and escalate issues, when required.
  • Participate in project activities and associated action items regarding on-going complaint handling improvement efforts
KEY PERFORMANCE INDICATORS:
  • No major non-compliance in applicable process/records
  • Non-product feedback closure timeliness
  • Complaint record compliance completeness and timely closure
  • Complaint closure performance
  • Support in process improvement activities.
REQUIRED COMPETENCIES:
  • Bachelor s degree preferably in Engineering, Science, healthcare, nursing or related technical degree.
  • 8+ years of related experience in a medical device or regulated industry preferably in complaint handling, adverse event reporting and related processes.
  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169. Working knowledge in Risk Management (ISO14971) will be considered a plus.
  • Local post market surveillance regulation (21CFR, MDD93/42/EEC, other applicable market regulations),
  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Product knowledge is preferred.
  • Good analytical skills and focus on detail.
  • Process improvement capabilities with the ability to resolve complex issues in creative and effective ways.
  • Strong written and oral communications skills in English.
  • Ability to work in a demanding environment
Why should you join Philips Working at Philips is more than a job. It s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.To find out more about what it s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.ContactIf you forgot your password, you can click theForgot Passwordbutton on the Sign In screen to reset it.If you have any other questions regarding the recruitment process please refer to ourFAQs.In case of technicaldifficulties with the website,please send an emailto careersite@philips.com .(Note: To ensure fairness and legal compliance in our recruitment processes,only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)ContactIf you forgot your password, you can click theForgot Passwordbutton on the Sign In screen to reset it.If you have any other questions regarding the recruitment process please refer to ourFAQs.In case of technicaldifficulties with the website,please send an emailto careersite@philips.com .(Note: To ensure fairness and legal compliance in our recruitment processes,only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.),

Keyskills :
adverse event reportingmedical devicesiso 13485iso 14971post market surveillancerisk assessmentmedical device directive21 cfrfield servicerisk managementcontinuous improvement facilitationinternal audit

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