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.

Stay up to date with RefleXion by following our channels here:

LinkedIn, X (formerly Twitter), Instagram, Facebook, and YouTube.

About This Role 

The Associate Quality Engineer will be responsible for assisting in establishing, implementing, and maintaining systems to measure and improve product quality and cost while ensuring full compliance to FDA and applicable ISO requirements. The Associate Quality Engineer will also assist in establishing and monitoring systems related to Manufacturing (Nonconformance Reports (NCRs), Reworks and Deviations), Testing, Training, New Product Introduction (NPI), Inspection, Complaints, Preventive Maintenance and Calibration (PMC) and Corrective/Preventative Action.

What You Will Be Doing 

  • Maintain calibration and preventive maintenance database, including publishing periodic upcoming and past due Cal/PM, process new and existing equipment for calibration and review calibration reports
  • Facilitate risk assessment activities associated with equipment that are found to be out of tolerance following routine calibration through NCR process, including performing investigation; escalate risk concerns to management for potential containment activities
  • Review, escalate and resolve Quality issues occurring within the organization including manufacturing issues and supplier issues
  • Review, handle, and process NCRs, Reworks, Deviations, and Change Orders
  • Work with suppliers for NCRs occurring in Incoming Quality Control (IQC) to implement Corrective/Preventive Actions as needed
  • Analyze and present Quality Data such as, but not limited to, Scrap Rates, IQC Acceptance Rates, CAL/PM data to identify trends and implement corrective actions
  • Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR: Part 820), ISO13485:2016, and all other applicable regulations and standards
  • Serve as a data lead for the quality engineering team
  • Support other Quality Systems and Quality Engineering/Assurance elements as needed (Corrective and Preventive Actions (CAPAs), NCRs, Design Quality, Document Control, Complaints, Compliance, Audit, Supplier Controls, CAL/PM or IQC)
  • Drive continuous improvement initiatives to Quality processes by updating the Quality System SOPs/Wis and Computer Systems (e.g. Arena & QAD)
  • Create and maintain monthly metrics and reports
  • Support the development of functionality within the PLM or ERP software system in support of Quality Processes (SCAR, SCR, Deviations, NCRs, Reworks, etc.) or other new processes
  • 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

  • Bachelor of Science (BS) degree in Engineering, Life Sciences, or related field
  • Some experience and/or coursework, internship, and/or professional work dealing in engineering, quality, design, etc.
  • Excellent written and oral communication skills
  • Strong organizational, problem-solving, root-cause and analytical skills
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
  • Ability to safely lift 20lbs
  • Wiling and able to work in an office and also near a Radiation Bunker housing the RefleXion machines in the Factory and the R&D Lab on occasion
  • Proven ability to handle multiple projects and meet deadlines
  • Good judgment with the ability to make timely and sound decisions
  • Acute attention to detail

Ways To Stand Out 

  • Bachelor of Science (BS) degree in Mechanical Engineering preferred
  • Calibration and preventive maintenance experience
  • Led or participated in performance improvement projects
  • Experience with nonconformance investigation and root cause analysis 
  • CQE or CQA certification

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 $70,000 - $90,000 annually.   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.

Apply for this Job

* Required
resume chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
When autocomplete results are available use up and down arrows to review
+ Add another education

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in RefleXion Medical’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.