Complaint Handling Manager

Recor Medical • Palo Alto, CA

273d • $118,289 - $148,101

About The Position

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe. The Complaint Handling Manager is responsible for the support and administration of Quality Systems and ensuring compliance with policies, procedures, and regulatory requirements. The individual will work independently and collaboratively to design and implement quality system solutions.

Requirements

• Minimum of 5 years in Quality Assurance/Quality Engineering role from Medical Device.
• Bachelor's degree in engineering discipline or equivalent.
• Regulations experience in any: FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• In-depth knowledge of medical device complaint handling requirements and process.
• Working knowledge of design controls, risk management, process validation, and statistical techniques.
• Strong written and verbal communication skills and ability to collaborate effectively.
• Proficient in the use of Microsoft Office Suite.

Responsibilities

• Support company goals and objectives, policies, and procedures.
• Drive complaint handling processes and processing of returned material authorizations, including root cause investigation and closure.
• Perform product investigations, inclusive of working in a wet lab with bio-hazard materials to be decontaminated from returned products.
• Initiates and manages complaints in our Quality Management System (QMS).
• Performs Product Quality Complaint Investigations and drives closure of associated CAPA(s).
• Manages Annual Product Quality Reports collaborating with internal stakeholders.
• Evaluates scientific data for trends, drives Investigations, and proposes the need for changes to manufacturing or control procedures.
• Collaborate with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
• Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.
• Coordinate technical analysis of complaint devices with engineering teams.
• Gather and analyze quality system data and metrics around complaints.
• Identify and flag complaint trends that require follow-up and additional investigation.
• Communicate cross functionally on complaint findings, outcomes.
• Perform timely determinations of reportability on complaints.
• Coordinate with regulatory and medical affairs on complaints that require reporting.
• Flag when complaints should be evaluated for additional actions such as CAPA, field actions or notifications.
• Drive the initiation of health hazard assessments when information is received that suspects a safety concern.
• Create, revise and review SOPs and maintain compliance to regulations and ISO requirements.
• Support change control processes including document control and training.
• Support the internal audit processes and management review.
• Support the quality-related aspects of new hire orientation.
• Act as an administrator of the quality management software.
• Update and maintain proper Quality System records, reports, and statistics.

What This Job Offers

• Job Type: Full-time
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree