Description

Company Overview

NextBeam is an irradiation service provider founded with the vision of improving how contract irradiation gets done, serving industries including lab supply, medical device, pharmaceutical, food, and others. Our mission: be the most customer-centric irradiation provider in the world. We value teammates that are accountable, detail-oriented, customer-oriented problem solvers. Together, we cultivate a startup mentality and culture to operate at a high level of quality and reliability, work collaboratively, and take the initiative to identify and solve problems across our business.

Summary

The QA/Site Supervisor is a quality professional with day to day responsibility for site management. From a quality perspective, this role involves designing, planning, prioritizing, executing, reviewing, and reporting results of tests performed in the QA lab as well as other related duties necessary to operate within a highly regulated environment such as supporting quality events (audits, corrective actions, investigating nonconformances), maintaining calibrations, document control, and training. From a site management perspective: the Supervisor is the most senior NextBeam person onsite and has responsibility for assuring operations run as planned in conjunction with our manufacturing partner.

Essential Duties: Quality

• Establish and maintain good technical understanding of relevant industry standards and regulations (ISO 13485, ISO 11137 series, ISO 11737 series, ASTM 51649, ASTM 52303) in order to design and perform testing with appropriate test methods, sample sizes, statistical techniques, and acceptance criteria.
• Collect, analyze, and report data to release / reject product batches and other studies
• Maintain calibration of laboratory equipment and tools
• Investigate, root-cause analyze, and provide disposition when quality events occur
• Maintain document control including developing new and updated procedures, forms, templates and recordkeeping systems
• Support audits by customers, regulators, and other groups including understanding and communicating how we meet applicable requirements, planning and implementing corrective actions
• Maintain a high level of quality and integrity even under challenging conditions such as undesirable test results or during customer or regulatory audits
• Collaborate with other functions to convey the importance of quality control including how quality control affects and is affected by other functions
• Schedule, prioritize, and communicate status of testing according to a variety of factors including internal, customer, and compliance requirements
• Maintain inventory of lab supplies and consumables
• Maintain accuracy and completion of sample inventory and other logs
• Assist with data trending and analysis for monitoring validated processes and supporting changes when necessary
• Assist with establishing schedule and responsibilities for lab personnel to drive customer and employee satisfaction
• Participation in industry standards development and updating internal documentation for continuing compliance as standards and regulations are revised

Essential Duties: Operations & Leadership

• Understand and be able to operate NextBeam’s Enterprise Resource Planning (ERP) system to receive, work order, and invoice jobs
• Maintain strong and proactive communication with our onsite manufacturing partner
• Assure that the small (1-3 person) onsite NextBeam team is trained and and organized
• Provide first-line guidance to help junior staff perform their designated tasks
• Assure NextBeam meets its obligations to customers in conjunction with our Customer Service team

Requirements

Required Qualifications:

• College diploma or equivalent
• 3+ years in quality control or a related function
• Ability to communicate with native or bilingual proficiency in English including reading, writing, listening, and speaking in a professional and technical manner with internal and external groups
• Very strong skills with Microsoft Office applications (Word, Excel)
• Ability to lift 30lbs., sit or stand for long periods of time.
• Strong skills in mathematics and statistics

Preferred Qualifications:

• AAMI CISS-RAD certification
• Industry training for quality control, document control, or auditing
• Experience working in a highly regulated environment (medical device, pharmaceutical, aerospace, semiconductor or similar)
• Working knowledge of good documentation practices (GDP), good manufacturing practices (GMP), quality systems (ISO 9001 or ISO 13485)
• Experience working in a laboratory environment and using lab equipment
• Experience with performing and maintaining calibrations or other verification / validation processes
• University courses in statistics and/or calculus
• Six sigma certification (yellow, green, black) for statistical analysis