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Product Complaint Analyst
Participate in product quality activities, including complaint evaluation and 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 support as needed
- Identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner
- Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
- Participate, facilitate, and/or support complaint investigations
- Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs)
- Provide support in the execution of field actions
- 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 “monitor” activities of QA mailbox
Complete other activities as assigned
- Minimum 2 years’ experience in life sciences industry or research; direct experience working in medical device / in-vitro diagnostics (IVD) industry preferred
- Familiar with quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDD)
- 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 with creation of concise, accurate reports
- Use of Microsoft Office Products and standard office equipment, ability to multi-task in a fast-paced environment and manage changing priorities.
- Strong working knowledge of statistical methods
Date Posted: 3/13/2020
Hiring Organization: Connexion Systems & Engineering
Job Title: Product Compliant Analyst
Location: San Diego, CA 92101
Employment Type: Full Time, Contract
Pay Range: 38/hr.
Duration: 4 months+
Job #: bh11203
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776