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.

Responsibilities

As a Quality Engineer, the selected individual will support medical device product development and quality system compliance across a dynamic, cross-functional environment. Responsibilities may include:

• 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

Key Qualifications

• 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.

Preferred Qualifications

• 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

Compensation Data

Battelle is committed to fair and equitable compensation practices. The salary range for this role is $85,320 - $104,280 per year, in addition to our comprehensive benefits package. A candidate's salary is determined by various factors, including but not limited to education, relevant work experience, skills, and certifications. Salary ranges may vary based on geographic location and market conditions.

Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.

• Balance life through a compressed work schedule: Most of our team follows a flexible, compressed work schedule that allows for every other Friday off-giving you a dedicated day to accomplish things in your personal life without using vacation time.
• Enjoy enhanced work flexibility, including a hybrid arrangement: You have options for where and when you work. Our Together with Flexibility model allows you to work 60% in-office and 40% remote, with Monday and Tuesday as common in-office days, dependent on team and position needs .
• Take time to recharge: You get paid time off to support work-life balance and keep motivated.
• Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
• Better together: Coverage for partners, gender-affirming care and health support, and family formation support.
• Build your financial future: Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.
• Advance your education: Tuition assistance is available to pursue higher education.