Support Post Market Regulatory Compliance activities domestically and internationally to ensure that complaints, are processed in a uniform and timely manner. This position is responsible for ensuring that complaint investigations are thorough, and are written with detailed, accurate statements. Escalate issues to CAPA as required. Required to communicate in an effective manner with internal employees, the sales force, and medical professionals. Cooperates with a staff of salaried and technical employees. Must be committed to corporate goals of customer satisfaction and continuous improvement.
Principal Duties and Responsibilities
• Process product complaints in a uniform and timely manner per established procedures.
• Conduct product testing and evaluation to document accurate and thorough complaint investigations including review of DFMEA, PFMEA and manufacturing documents where appropriate to ensure adequate identification, evaluation & investigation of an assignable root cause.
• Ensure quality issues are managed according to procedure and ensure adequate corrective/preventive actions are effective to eliminate/mitigate the issue.
• Escalate complaints to IE Request, SCAR and HHE as applicable.
• Support the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements) in relation to the complaint investigation activities.
• Provide feedback and support to the Product Development Team for Hazard Analysis and Risk Management Files.
• Provide complaint related data search, analysis and response to Regulatory Inquiries.
• Participate in internal and external departmental audits and responses to cited issues.
Expected Areas of Competence
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple levels of the company.
- Demonstrates characteristics of high potential for future development opportunities.
- Microsoft Office Suite
- Basic knowledge of blueprint reading and geometric dimensioning and tolerance, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods.
- B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
- 0-3 years of work experience.
- Certified Quality Engineer (CQE) and Medical device experience preferred
- Combination of education and experience may be considered (in evaluating experience relative to requirements)
Up to 20%