Senior Product Complaints Analyst

Job Description

Position Summary

Participate in product quality activities, including complaint investigations of company products. Facilitates cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated. Lead functional area initiatives as needed. Provide colleagues guidance and support as needed.

Responsibilities

• 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 escalates 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

Education

• Bachelor s degree in an engineering or science discipline desired; advanced degree preferred
• Quality Certification a plus (e.g., CQA, CQE)

Experience

• 5-7 years experience in life sciences industry or research; direct experience working in medical device / in-vitro diagnostics (IVD) industry preferred
• 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

Skills

• 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)

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.