The Quality Engineer develops, applies, revises and maintains quality assurance protocols and methods for the company. Responsible for planning, implementing and managing compliance of QMS design control, production control, and customer complaint processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Performs analysis of reports and production data and/or customer complaint data to identify trends and recommend updates or changes to quality standards and procedures when necessary. Assure compliance to in-house and/or external specifications and standards, (i.e. QSR, ISO, GLP, GMP, Six Sigma). May specialize in function specifically as it applies to biological licensing agreements.
ESSENTIAL DUTIES AND RESPONSIBILITIES: • Provides quality oversight to Development, Operations and Customer Complaint QMS Processes. • Reviews and approves the following: various design control and QMS documents. • Provides Quality Engineering support to company including IT, Operations, R&D, and Field Support (e.g., FSE/ATS). • Performs internal and external quality audits. • Other duties as required.
KNOWLEDGE, SKILLS & ABILITIES: • Ability to quantify the fundamental risks and problems associated with implementing development support processes and to assess, support, and implement process and technology changes. • Thorough understanding of verification and validation methodologies, design controls, and risk management. • Ability to utilize tools like Excel to analyze and trend data. • Excellent written and verbal communication skills. • Attention to detail and commitment to accuracy and quality. • Understanding of FDA Quality System Requirements (21CFR820) and International Standard Organization (ISO) 13485 regulations. • Ability to apply project management principles and techniques as they apply to planning, implementation and tracking. • Strong knowledge and skill with using MS office applications including Outlook, Excel, Word and PowerPoint. • Ability to create and maintain trend charts supporting, monitoring, and measuring activities. • Knowledge of MasterControl or similar eDMS required.
MINIMUM EDUCATION & PREVIOUS EXPERIENCE REQUIRED: • Bachelor’s degree in a related field • Netsuite or similar ERP system knowledge required • Minimum of 2+ years Quality Engineering preferably with regulated medical devices • Certified Quality Engineer (CQE) preferred
Agena Bioscience is dedicated to advancing the impact of genomics in healthcare and precision medicine. Our highly sensitive and cost-effective mass spectrometry-based platform, the MassARRAY® System, is used globally in diverse fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research.
Our mission is to equip genomic and clinical testing laboratories with practical solutions that increase productivity and decrease time to results. Whether assessing sample quality, screening samples for actionable mutations, or enabling routine genetic testing for tens to thousands of samples, our products and services help laboratories translate genomic discoveries into mainstream clinical practice.