RefleXion Medical · 8 hours ago
Manager of Quality Compliance - REMOTE
Remote - US
Full-time
Remote
Mid, Senior Level
$100K/yr - $165K/yr
7+ years exp
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Responsibilities
Responsible for processing complaints, training on the complaint process and facilitating investigation throughout the complaint lifecycle to ensure proper documentation and timely closure
Own complaint investigations and collaborate with the investigators of complaints to document to closure
Lead Complaint Assessment Board (CAB) to perform 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, as well as serve as a backroom subject matter expert (SME) for complaint processing, complaint investigation, MDR assessments, QNCRs, and CAPAs.
Responsible for processing QNCRs throughout the lifecycle to ensure proper documentation and timely closure, Leads QNCR Review Board to facilitate timely closure of open QNCRs, track Internal audit OFIs and review escalations
Responsible for processing 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
Qualification
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Required
Bachelor's of Science (BS) in Engineering, Sciences, or similar field
Minimum of 7 years of experience in medical device or relevant industry required
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
Preferred
Previous complaint handling experience - CAPA ideally - with class II medical device strongly preferred
Experience performing internal audits preferred
Previous Trackwise setup experience preferred
Previous radiation therapy or similar capital equipment a plus
Benefits
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
Company
RefleXion Medical
RefleXion Medical is a developer of biologically-guided radiotherapy systems for patients with cancer.
201-500 employees
H1B Sponsorship
RefleXion Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (8)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageTotal Funding
$675.1MKey Investors
The Rise FundAscension VenturesAlly Bridge Group
2023-11-15Series Unknown· $105M
2022-07-06Debt Financing· $125M
2022-03-10Series E· $80M
Leadership Team
Todd Powell
President and CEO
Sam Mazin
Founder and CTO
Recent News
Radiology Business
2024-05-04
2024-04-06
Company data provided by crunchbase
