Who We Are
RefleXion transforms radiopharmaceuticals from diagnosing cancer to actively controlling delivery of external-beam radiotherapy by leveraging individual tumor biology. Designated an FDA Breakthrough Device, RefleXion’s SCINTIX™ biology-guided radiotherapy automates targeting and motion management to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. In strategic collaborations with radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiotracers for difficult to treat late-stage cancers.
Find out more about RefleXion and SCINTIX therapy at reflexion.com.
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About This Role
The Quality Technician will perform a variety of inspection and quality tasks in support of manufacturing operations and new product development activities. Perform daily activities in the IQC lab including completion of inspections while meeting priorities. Assure compliance with the RefleXion Medical Quality Management System (QMS).
What You Will Be Doing
- Complete inspection of incoming materials including machined components, sheet metal parts, mechanical assemblies, printed circuit board assemblies, fasteners, and adhesives, per engineering drawings, specifications, and Quality Inspection Plans (QIP).
- Lead and implement best measurement techniques for incoming inspection.
- Review supplier provided documentation including certificates of conformance, material certifications, and special process certifications.
- Complete material acceptance and rejection transactions in ERP system.
- Coordinate MRB activities and initiate NCR’s as required to ensure the proper disposition of non-conforming materials as required in the QMS.
- Complete and review First Article Inspections (FAI) as required.
- Create or assist in generating Quality Inspection Plan (QIP)
- Monitor performance of quality control systems to ensure effectiveness and efficiency.
- Perform manufacturing in-process and final inspections per inspection plans as required.
- Assist in calibration and preventive maintenance activities with outside suppliers.
- Perform and/or participate in quality system audits as assigned, report findings, and make suggestions for improvement.
- Support new product development activities as needed.
- Perform all other duties as assigned.
Where You Will Do This Job
- Onsite - This position requires the successful candidate to work from the RefleXion office. They must be based in the greater SF Bay Area and must be able to commute into the RefleXion office in Hayward daily.
What We Need
- Minimum of 10 years of inspection experience, preferably in the medical device industry.
- Understanding of 21 CFR 820 Regulations and ISO 13485 Standards.
- Ability to read and interpret engineering drawings required.
- Solid proficiency in GD&T required.
- Working knowledge in the use of standard metrology tools including surface plates, calipers, micrometers, height gages, bore gages, indicators, pin gages, and gage blocks.
- Experience programing and operating coordinate measuring machines (CMM)
- Familiar with vision systems and optical comparators.
- Working knowledge of gage R&R, test method validation & equipment qualification.
- Understanding of statistical process control (SPC).
- Excellent verbal and written communication skills with attention to detail.
- Must be motivated and work with minimal supervision in a start-up fast-paced environment.
- Computer skills including Microsoft Office (Word & Excel), email, and other common programs.
- Ability to lift up to 50 pounds.
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 – hybrid work environment for many positions
- 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)
- 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 $36.00 - $60.00. 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.