Quality Compliance Manager

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RefleXion Medical

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cancer care • radiation therapy • life sciences • medical devices • biotechnology

201 - 500 employees

Founded 2009

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 $125M Debt Financing on 2022-07

Description

• RefleXion elevates radiopharmaceuticals from drugs that help identify cancer to guides that actively direct external beam radiotherapy by leveraging tumor biology. • The Manager of Quality Compliance will be the initial contact for all post-market surveillance activities and lead the following QMS programs: Complaints, QNCR, Internal Audits, and CAPA. • This person will be responsible for monitoring and managing complaint processing (including monitoring reporting assessments of complaints), CAPA process, QNCR process, and related metrics reporting. • This includes working cross-functionally to investigate product malfunctions, product design and/or labeling questions, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status.

Requirements

• 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

Benefits

• 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