Salary Range:$69,000.00 To $100,000.00 Annually
Position/Title: Post-Market Analyst
Department: Quality Assurance
Supervisor: Quality Systems Specialist
FLSA Status: Exempt
About the Company: Valencia Technologies is a neuromodulation company transforming the standard of care for urgency urinary incontinence with the development of our revolutionary eCoin technology. Valencia Technologies is ramping up all aspects of business to deliver effective therapy and impact the lives of millions. Join our mission to become the market leader in overactive bladder care as we bring patients and physicians a better therapy now and beyond, put patients first, and be a place of respect, excellence, and honesty for our employees and clients.
Job Summary: The Post Market Analyst is responsible for maintaining the VTC complaint system, as well as performing an analysis/trending of complaint data, and driving quality improvements to address customer complaints.
Responsibilities/Tasks: As the Post-Market Analyst, you will be responsible for:
• Ensure that complaints are accurately, concisely, and appropriately captured in the VTC complaint system.
• Process the complaints according to established complaint procedures. This includes determining of a reported issue is an actual complaint, ensuring complaints are thoroughly investigated, and ensuring complaints are closed in a timely and compliant manner.
• Review customer complaints, determine reportability based on regulatory standards, and categorize complaints according to severity and potential safety concerns.
• Analyze complaint data to identify trends, patterns, and potential safety signals, including using statistical methods to assess the significance of findings.
• Prepare and submit necessary regulatory reports to relevant authorities like the FDA, including Medical Device Reports (MDRs) and Vigilance Reports, ensuring timely and accurate reporting.
• Train new employees on the complaint process and the complaint system
• Collaborate with other departments like customer service, engineering, and sales to gather information, share findings, and implement corrective actions.
• Other duties as assigned
Qualifications:
• Bachelor's degree
• Excellent attention to detail and critical thinking skills
• Understanding of relevant regulatory standards (e.g., FDA QSR Part 820, ISO 13485)
• Experience with complaint handling systems is desirable
• Excellent analytical and problem-solving skills
• Strong written and verbal communication skills to effectively document findings and communicate with stakeholders
• Proficiency in Microsoft Office Suite, particularly Excel & Access
Benefits:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401K with Employer Matching
- Paid Time Off
- Paid Holidays
- Professional Development Reimbursement
- Annual Bonus Eligibility
Valencia Technologies is proud to be an equal opportunity workplace and is an affirmative action employer