Overview

Purpose:

This role is responsible for all quality processes associated with product complaint handling, procedures and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.

Responsibilities

Complaint Handling and Investigation

• Manage the end-to-end complaint handling process, including intake, customer, patient and sales representative follow ups, evaluation, investigation, and resolution.
• Review documentation from incoming calls, other communications and emails from all areas of the world.
• Support and coordinate technical root cause analysis which may include technical design and device performance analysis.
• Ensure complaints are assessed for reportability under applicable regulations (e.g., FDA 21 CFR Part 803, EU MDR, CMDR, MHRA).
• Obtain adequate information to ensure proper documentation, investigation (including testing devices and log analysis), and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
• Collaborate with cross-functional teams (R&D, manufacturing, and customer service) to investigate and resolve complaints.

Statistical Methods for Symptom Code and Root Cause Trending

• Apply standard practices and techniques in specific situations, adjust and correlate data, recognize discrepancies in results, and follow operations through a series of related detailed steps and processes.
• Utilize advanced statistical methods to perform trending and analysis of symptom codes and root causes from complaints leveraged from the International Medical Device Regulators Forum (IMDRF) Appendix A and D.
• Implement data visualization tools to identify emerging trends in product issues and prioritize corrective actions.
• Use statistical techniques, such as Pareto analysis, control charts, and regression analysis, to track and monitor recurring complaint patterns.

Regulatory Compliance

• Ensure compliance with global regulatory requirements, including FDA, ISO 13485, CMDR, MHRA and EU MDR, in all complaint handling activities.
• Manage and submit required regulatory reports, such as Medical Device Reports (MDRs) or Vigilance Reports, within the prescribed timelines.
• Interface appropriately with Notified Bodies when required.
• Collaborate with Medical Affairs to support complaint investigations that require clinical evaluation or medical assessment.

Data Management and Analysis

• Maintain accurate and thorough complaint records in the electronic QMS or complaint database.
• Perform trend analysis on complaints to identify recurring issues and initiate corrective and preventive actions (CAPAs) as needed.
• Work with Clinical Affairs/Medical Affairs when complaints require clinical assessments.
• Conduct risk assessments and, where hazards are not identified or risk severity changes, collaborate cross-functionally to complete a Health Hazard Evaluation (HHE).

Audits and Inspections

• Support internal and external audits by providing complaint handling documentation and responding to auditor inquiries.
• Ensure readiness for regulatory inspections related to complaint handling activities.

Process Improvement

• Continuously improve the complaint handling process to enhance efficiency and effectiveness.
• Develop and implement training programs for staff on complaint handling and reporting procedures.
• Perform additional duties and initiatives as assigned by management to support business objectives.

Supervisory Responsibilities:

This person has supervisory responsibility.

Qualifications

Education and Experience:

• Bachelor's degree in Systems, Mechanical, Electrical, Software, Biomedical Engineering or related technical field highly desirable

• Master's degree in a relevant engineering field is preferred, demonstrating a deeper understanding of Systems Engineering principles and their application in the medical device industry

• 8+ years of relevant Systems, Software, Mechanical design or related experience required

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

1. Strong analytical and problem-solving skills
2. Excellent written and verbal communication skills
3. Ability to work effectively with cross-functional teams and manage multiple priorities
4. Knowledge of QSR's and their application
5. Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
6. Ability to manage multiple responsibilities with a high degree of self-motivation
7. Proficiency in Microsoft Office Suite with advanced Excel skills required, including data analysis and reporting capabilities.

Work Environment:

Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The work environment also includes warehouse and manufacturing areas.

Physical Demands:

Occasionally lift or move objects weighing up to 10 pounds, such as files, equipment, or samples.

Benefits

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

Pay Transparency

The base pay range for this role in California is $102,800 to $141,350 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.

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