Title: Complaint & CAPA Coordinator
Department: Quality Assurance
Reports to: Director of QA/RA
Direct Reports: N/A
Ensures that the company's products consistently meet or exceed established quality standards. Responsible for day to day Quality System processes and tasks including Complaints, Nonconforming Materials Processing, CAPA and Deviations.
- Ensure that company quality standards for manufactured and repaired products are adhered to consistently.
- Responsible for complaint handling, nonconforming material report processing and CAPA systems.
- Conduct investigations, root cause analysis (5 why's, 8D, Ishikawa Fish bone diagrams, 5Ms, fault/risk analysis), properly document findings within complaint files and nonconforming material reports. Execute and document applicable corrective actions, Nonconforming Materials Notices and formal CAPAs as necessary. Close complaints and nonconforming material reports in a timely manner.
- Communicate and advise customers on complaint responses and product complaint dispositions.
- Notify management of any potential adverse events and/or field actions. Support mandatory reporting to applicable agencies and support related field action activities.
- Support supplier communications on NCMRs and coordinate Supplier Corrective Actions.
- Responsible for QA trending and reporting of complaints, CAPA, failure modes and NCMRs and other trending reporting as assigned.
- Support of customer product QA/RA needs.
- Perform other duties as assigned.
- Maintain current procedures.
- Collaborate with other departments and functions as needed.
SKILLS AND QUALIFICATIONS:
- Knowledge and understanding of Quality System Regulations/cGMPs and ISO 13485 Quality System Standard.
- EU medical device regulations are a plus.
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to perform root-cause analysis, problem solve and analyze trends and draw logical conclusions.
- Understand manufacturing and production systems to comprehensively investigate problems and plan and execute applicable corrective actions.
- Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills. Proficiency in Access and ERP systems is a plus.
- Critical thinking, facilitation, negotiation skills and collaboration abilities essential.
- Manage nonconforming products, complaints and CAPAs in a timely manner and maintain related records.
- Develop new ideas and strategies to improve procedures or policies.
- Ascertain integrity of procedures.
- Ensure that work is being performed in accordance with documented procedures.
- Seek to improve and make changes in procedures to document "best practices".
- Keep up with applicable industry standards, regulations and stay informed of organizational changes.
- Remain well prepared for audits by external agencies/organizations (including, but not limited to FDA, ISO, EPA, OSHA).
- Sustain safe work environment.