Manager of Quality Compliance - REMOTE

Who We Are

RefleXion elevates radiopharmaceuticals from drugs that help identify cancer to guides that actively direct external beam radiotherapy by leveraging tumor biology. Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX® biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates targeting and motion management for use in FDG-guided treatment of lung and bone tumors that arise from primary lung and bone cancers or are metastases from other primary cancers. In strategic collaborations with industry-leading radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiotracers for treating late-stage cancers.

Find out more about RefleXion and SCINTIX therapy at reflexion.com.

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About This Role 

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. This role will monitor metrics and drive process improvements based on performance trends. This individual will contribute substantially to the Complaint Handling and field action / recall processes, QNCR & CAPA requirements, including updating SOPs and Work Instructions to ensure compliance with domestic regulations such as 21 CFR Part 820.198, Part 7, and Parts 803 & 806, and build processes to be compliant with evolving global regulations and standards such as the EU- MDR, ISO13485, and relevant provisions of ISO 14971. The incumbent for this position will support additional activities as assigned. 

What You Will Be Doing 

• 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

Where You Will Do This Job  

• Remote - This position will allow the successful candidate to work a primarily remote schedule. They must be based in the US and may be required to come into the RefleXion office in Hayward for meetings and other events as needed.

What We Need

• 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

Ways To Stand Out 

• 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

What You Will Love About Working with Us!

• The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
• Flexible work location and schedule available for many positions - see above for specific work location for this position
• 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

The pay range for this role is $100,000 - $165,000 a year.   Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Values and Diversity 

RefleXion is an equal opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, disability/medical​​​ condition, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.