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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

The Project Quality Specialist provides project support to medical device product development teams. This role prepares documentation packages for data collection, completes document reviews in alignment with Good Documentation Practices (GDP), manages post‑processing and routing (including DocuSign/e‑signature envelopes), performs document review and reconciliation, and serves as a backup witness for testing activities. The Specialist partners closely with project members across multiple disciplines – engineering, quality, project managers, customers – to maintain complete, accurate records under an ISO 13485 compliant Quality Management System.

Responsibilities

+ Manages project file documents through the site document control system.

+ Prepares documents for data collection; ensures correct versioning and aligns formats and templates to internal standards and quality system requirements before distribution.

+ Enforces Good Documentation Practices (GDP) in records; escalates issues, if identified.

+ Completes document review and reconciliation: performs completeness checks, traces data to source, and resolves discrepancies with authors/testers.

+ Collects, reconciles, and processes executed records; routes for review/approval via DocuSign or eQMS workflows.

+ Serves as secondary witness for testing when required; confirms forms are prepared, entries made contemporaneously, and witnessing meets procedural requirements.

+ Provides administrative project support.

+ Monitors training compliance and project conformance to the Quality Management System requirements, customer requirements, and regulations.

+ Collaborates with cross-functional teams to support quality objectives.

+ Interfaces with internal stakeholders and contributes to customer quality support, as needed.

+ Identifies recurring issues and escalates opportunity improvements to Project Manager, Quality Engineer, and/or Quality System Manager to drive continuous improvement, efficiency, and compliance.

Key Qualifications

+ Associates Degree in a related field and/or 2 years of applicable technical experience in document control, quality assurance or regulated operations in a medical device or closely related field.

+ Experience working under an ISO registered Quality Management System or related regulated environment in document control systems and processes.

+ Excellent proof-reading skills with attention to detail.

+ Strong organizational and communication skills.

+ Strong computer skills, particularly proficient with Microsoft Office (e.g., Word, Excel).

Preferred Qualifications

+ Exposure to customer quality interactions.

+ Working knowledge of FDA 21 CFR 820, ISO 13485, GLP/GMP principles and Good Documentation Practice(s) (GDP), with emphasis on data integrity in test execution and recordkeeping.

+ Experience in electronic system process flows and e-signature routing (e.g. DocuSign).

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.

A Work Environment Where You Succeed

For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.

You will have the opportunity to thrive in a culture that inspires you to:

+ Apply your talent to challenging and meaningful projects

+ Receive select funding to pursue ideas in scientific and technological discovery

+ Partner with world-class experts in a collaborative environment

+ Nurture and develop the next generation of scientific leaders

+ Give back to and improve our communities

Vaccinations & Safety Protocols

_Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws)._

_Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle._

The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. **No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.**

For more information about our other openings, please visit www.battelle.org/careers