Quality Compliance Manager

Summary

Join RefleXion as the Manager of Quality Compliance, where you will be the primary contact for post-market surveillance and lead key QMS programs. You will oversee complaint processing, CAPA, and QNCR processes, ensuring compliance with domestic and global regulations. This role involves investigating product issues, monitoring metrics, and driving process improvements. You will collaborate cross-functionally, contribute to field actions, and update QMS documentation. The position is remote, based in the US, with occasional office visits. RefleXion offers a competitive compensation and benefits package.

Requirements

• Bachelor's of Science (BS) in Engineering, Sciences, or similar field
• Minimum of 7 years of experience in medical device or relevant industry
• Advanced knowledge of Class II Medical Device Complaint files and quality record documentation
• Advanced knowledge of Quality Management System and Regulatory reporting requirements for Medical Devices (21 CFR Part 820.198 and 803 requirements, EU /MDR requirements)
• Ability to work effectively in a collaborative and dynamic environment
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, PLM and CMS
• Previous professional experience with digital complaint handling systems
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (quality, operations, engineering, medical affairs, clinical, and regulatory); strong written and verbal communication skills

Responsibilities

• Process complaints, provide training on the complaint process, and facilitate investigation throughout the complaint lifecycle to ensure proper documentation and timely closure
• Own complaint investigations and collaborate with investigators to document complaints to closure
• Lead Complaint Assessment Board (CAB) to review complaints per Medical Device Regulations, set priority, and identify ownership
• Maintain and validate the complaint handling system in Trackwise and the QNCR and CAPA automated processes in Arena
• Ensure on-time reporting of MDRs
• Establish and maintain Quality Data Metrics related to Complaints, CAPAs, QNCRs, and other QMS processes as assigned
• Support backroom during 3rd party audits and inspections, and serve as a backroom subject matter expert (SME) for complaint processing, complaint investigation, MDR assessments, QNCRs, and CAPAs
• Process QNCRs throughout the lifecycle to ensure proper documentation and timely closure
• Lead QNCR Review Board to facilitate timely closure of open QNCRs, track Internal audit OFIs and review escalations
• Process CAPAs throughout the lifecycle to ensure proper documentation and timely closure
• Lead CAPA Review Board to facilitate closure of open CAPAs, and review CAPA extensions and escalations
• Support Field Actions activities and PIRs/HHEs as assigned
• Draft and update QMS documentation as needed or assigned
• Contribute to QMS training decks ensuring that areas of responsibility are adequately represented
• Coordinate, plan and facilitate Agenda for all Internal Audits
• Own or support as a team member Quality Projects as assigned
• Other duties as assigned

Preferred Qualifications

• Previous complaint handling experience - CAPA ideally - with class II medical device
• Experience performing internal audits
• Previous Trackwise setup experience
• Previous radiation therapy or similar capital equipment

Benefits

• Flexible work location and schedule
• Competitive compensation and Pre–IPO stock option packages
• Medical (both HMO and PPO options), Dental and Vision
• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
• Pre-tax Commuter Benefits
• Employee Assistance Program (EAP)
• 401(k)
• 3 Weeks/Year PTO Accrual rate to start and 12 Paid Company Holidays
• Employer paid Life Insurance, short-term and long-term disability
• RefleXion Benefit Hub –Company exclusive discounts and deals on a variety of sites and items
• Weekly catered on-site lunches as well as kitchens filled with a variety of healthy and delicious food and drinks – including an espresso machine and panini stations!
• Employee Events – Variety of Workshops, Lunch ‘n Learns, Financial Wellness education, Regular “Coffee Chats” with Executive Leadership, Scavenger Hunts, Company Milestone celebrations and more!
• Electric car charging stations on site