Philips India- Quality and Risk Manager

Requirements 

• Bachelor's degree preferably in Engineering, Science, healthcare, nursing or related technical degree.
• 6+ years of related experience in a medical device or regulated industry preferably in complaint handling, adverse event reporting and related processes.
• Understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• 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 "
   

"   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.

Work Description

• 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
• Analyzes complaint data, gathers additional data as needed, and partners cross functionally with field service engineers, complaint evaluation team and call center representatives.
• Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint. Support the screening of complaints for reported serious injury/deaths and the assignment to investigators within 2 business days.
• Assist the Vigilance Reporting team in collecting the required data for initial assessment of reportability as well as any request of information from Competent Authorities and Notified Body. 
• Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed.
• 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).
• Complete all needed records in a timely and accurate manner
• Escalate to the CHU manager when necessary to determine the action to drive timely and effective resolution of the complaint.
• 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
• Support internal audits when required by CHU Management."