Associate Quality Engineer - ONSITE at RefleXion

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 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.