Quality Engineer

Battelle•Columbus, OH

49d•$85,320 - $104,280•Hybrid

About The Position

Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency. We recognize and appreciate the value and contributions of individuals from a wide range of backgrounds and experiences and welcome all qualified individuals to apply. Job Summary We are currently seeking a Quality Engineer. This position is a full-time opportunity located in Columbus, OH, with a hybrid work schedule. Battelle is seeking a Quality Engineer (QE) to support medical device product development and independently execute Quality Management System (QMS) processes for the Medical Device Solutions (MDS) team. The QE will serve as an owner or key contributor across QMS processes including software validation, Computer System Validation (CSV), risk-based Computerized System Assurance (CSA), internal audits, document and records management, training, supplier management, and calibration. The QE is expected to demonstrate sound independent judgment, proactively identify opportunities for improvement, and drive assigned activities to completion — operating within applicable regulatory and quality standards including ISO 13485, FDA Quality Management System Regulation (21 CFR Part 820 QMSR), and the MDS QMS.

Requirements

Bachelor's degree in engineering, quality, or a related technical field; five years of relevant experience; or an equivalent combination of education and/or experience in engineering or quality roles within regulated industries
Working familiarity with ISO 13485, ISO 9001, AS9100, or related regulatory frameworks
Basic understanding of design controls, manufacturing quality, risk management, and statistical methods
Applicants must have authorization to work in the United States. We are unable to sponsor or take over sponsorship of any employment Visa at this time.

Nice To Haves

ASQ Certified Quality Engineer, Six Sigma Green Belt, or other industry-recognized quality certification or accreditation
Experience with QMS software and data analysis tools
Exposure to regulatory audits and customer quality interactions

Responsibilities

Lead risk-based validation of software and computerized systems, including planning, requirements, risk assessments, test protocols and reports, change control, and periodic review
Lead quality planning activities for product development by developing and maintaining project-level quality plans that define deliverables, applicable requirements, and quality activities
Lead or participate in root-cause analyses and nonconformance/CAPA investigations
Maintain the QMS in accordance with ISO 13485, 21 CFR Part 820 QMSR, internal procedures, and other applicable requirements
Contribute to risk management activities and documentation, taking initiative in identifying and mitigating risks
Participate in design reviews and assist in verification and validation testing
Author and maintain controlled procedures, work instructions, forms, training materials, and reference documents; support document control and records management
Coordinate the QMS training program, including curriculum assignments, role-based training matrix, training records, due-date monitoring, and escalation of overdue training
Facilitate supplier qualification and ongoing performance monitoring
Support the calibration program, including equipment inventory management, calibration event oversight, record reviews, and nonconformance assessments for out-of-tolerance findings
Monitor quality metrics and assist in reporting and trend analysis
Support certification, customer, and internal audits
Participate in design transfer activities and work with project teams to resolve quality issues
Support incoming inspection processes and sampling plan execution
Support continuous improvement projects to enhance quality and operational efficiency
Champion best practices and innovative approaches across the team
Collaborate with cross-functional teams to support quality objectives
Interface with internal stakeholders and contribute to customer quality support
Support Quality Assurance sections of proposals and provide budgetary estimates for QA efforts
Receive mentorship from Senior and/or Principal Quality Engineers and participate in training programs focused on developing leadership and technical depth