Senior Product Complaints Analyst

Overview

Participate in product quality activities, including complaint investigations of company products, and facilitate cross-functional discussions to identify, document, analyze and report quality issues.

What you'll do

• Identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner
• Support audits and/or inspections as needed
• Identify and lead product and process improvements to reduce complaints and cost of poor quality
• Actively participate on Quality and cross-functional project teams as needed
• Provide direction, training, support and implementation of quality initiatives for the department
• Develop and maintain complaint process documentation and provide cross-functional training
• Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
• Participate, facilitate, and/or support complaint investigations and resulting CAPA activities
• Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs)
• Provide support in the execution of field actions as applicable
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Write and critically review quality documents for internal and external distribution (e.g., investigation reports, SCAR responses, product quality notifications) and provide support and training to colleagues completing similar documents
• Participate and conduct tasks associated with rotational monitoring activities of QA mailbox

What you'll need

• Bachelor's degree in an engineering or science discipline
• 5-7 years' experience in life sciences industry or research
• Knowledge of quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDR)
• Exposure to complaint management, product development (design controls, risk analysis, validation) and post-market sustaining / maintenance (change controls, risk management, manufacturing quality, supplier management)
• Experience leading and/or managing cross-functional projects
• Use of Microsoft Office Products and standard office tools
• Ability to multi-task in a fast-paced environment and manage changing priorities with a high degree of self-motivation
• Good written, oral, and interpersonal English communication skills
• Willingness to work in shifts to support the US region (no night shift required)

Nice to have

• Advanced degree
• Quality certification (e.g., CQA, CQE)
• Direct experience working in medical device / in-vitro diagnostics (IVD) industry

Details

• Location: Bengaluru (Manyata), India
• Not eligible for visa sponsorship