Quality Technician - Temporary (ONSITE)
Company: RefleXion Medical
Posted on: January 21, 2023
Who We Are RefleXion is developing the SCINTIX biology-guided
radiotherapy machine that is the first to utilize the cancer's
biology itself to control radiation delivery, even in tumors that
are moving. By using positron emission tomography (PET),
RefleXion's platform enables a leap forward in the ongoing goal of
conventional radiotherapy to manage motion, and potentially
diminish radiation toxicity, making it feasible to one day provide
more options for patients with advanced stage cancer. Currently,
the RefleXion X1 machine is cleared by the U.S. Food and Drug
Administration (FDA) for the delivery of stereotactic body
radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity
modulated radiotherapy (IMRT). Find out more about RefleXion and
SCINTIX therapy at . Stay up to date with RefleXion by following
our channels here: LinkedIn , Twitter , Facebook , Instagram ,
YouTube . SCINTIX biology-guided radiotherapy is pending regulatory
review and is not commercially available. 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
- Provide work direction and guidance of issues relating to
quality of products and schedule attainment.
- 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
- Review supplier provided documentation including certificates
of conformance, material certifications, and special process
- Complete material acceptance and rejection transactions in ERP
- 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
- Create or assist in generating Quality Inspection Plan
- 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
- Support new product development activities as needed.
- Perform all other duties as assigned.
- Other duties as assigned Where You Will Do This Job
- Hybrid - This position will allow the successful candidate to
work on a Hybrid work location schedule. They must be based in the
greater SF Bay Area and must be able to commute into the RefleXion
office in Hayward 1-4 days a week, depending on the role. What We
- Minimum of 10 years of inspection experience, preferably in the
medical device industry.
- Understanding of 21 CFR 820 Regulations and ISO 13485
- Ability to read and interpret engineering drawings
- 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
- Familiar with vision systems and optical comparators.
- Working knowledge of gage R&R, test method validation &
- 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
- Employer paid Life Insurance, short-term and long-term
- 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
- Electric car charging stations on site The pay range for this
role is $24.00 - $48.00. 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.
Keywords: RefleXion Medical, Hayward , Quality Technician - Temporary (ONSITE), Professions , Hayward, California
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