Overview
Statewide Quality Assurance Director Med Jobs in Baltimore, MD at Centurion Health
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 / IQC (Incoming Quality Control) Technician is a temporary position within the Quality Assurance department that will perform a variety of inspection and quality tasks in support of manufacturing operations and new product development activities. This temporary assignment is expected to last six months, but could potentially turn into a longer engagement, with possible full-time conversion. The Associate Quality Engineer / IQC Technician will perform daily activities in the IQC lab including completion of inspections while meeting priorities and also 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
Ability to read and interpret technical drawings
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
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
High school diploma or general studies degree (GED) and 3 years professional inspection quality control (IQC) experience required – OR –
Bachelor’s (BS) degree in engineering discipline and some experience with IQC required
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
Familiar with vision systems and optical comparators
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 manage and make efficient use of your time and stick to parts inspection schedule
Ability to lift up to 25 pounds
Ways to Stand Out
Understanding of 21 CFR 820 Regulations and ISO 13485 Standards helpful
Previous experience working in an FDA regulated manufacturing environment preferred
Experience programing and operating coordinate measuring machines (CMM) helpful
Previous experience creating Quality Inspections Plans
Working knowledge of gage R&R, test method validation & equipment qualification
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 $28.00 – $41.00 an hour. 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.
Title: Statewide Quality Assurance Director Med
Company: Centurion Health
Location: Baltimore, MD
