DEKA is seeking a detail-oriented and proactive Quality Systems Project Coordinator to support the management and implementation of DEKA's Quality Management System (QMS). In this role, you will help execute quality initiatives while building your project management skills in a regulated, engineering-driven environment. Additionally,you'll work closely with Quality leadership, project managers, and technical teams to ensure that projects align with regulatory requirements.
Key responsibilities as aQuality Systems Project Coordinator:
- Coordinate and track quality-related projects to align with DEKA's quality goals and regulatory standards.
- Drive cross-functional execution by organizing tasks, following up with stakeholders, and ensuring timely progress.
- Support QMS implementation and improvements by addressing technical and process challenges.
- Collaborate with Quality and technical leaders to plan and manage deliverables tied to business and regulatory needs.
- Assist in prioritizing tasks, setting timelines, and managing resources to meet project goals.
Identify and mitigate project risks, resolve conflicts, and escalate issues when necessary. - Maintain QMS documentation, support change control, and assist with processes like CAPA, training, and design control.
- Contribute to process improvements that enhance QMS performance and compliance.
- Ensure QMS activities meet internal standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
- Support audit readiness by organizing documentation and working with internal teams.
What You Will Bring to the Team as aQuality Systems Project Coordinator:
- Strong ownership mindset with the ability to manage multiple priorities and drive critical deliverables.
- Proactive problem-solver who anticipates needs and addresses roadblocks independently.
- Reliable follow-through with a focus on accountability and task completion.
- Effective time management and adaptability in a fast-paced, shifting environment.
- Clear communicator, comfortable working across teams and technical backgrounds.
- Sharp analytical and organizational skills to structure and simplify complex work.
To be successful in this role,the following skills and experience are required:
- BS in Engineering, Life Sciences, or a related field
- 1+ years of experience in a quality or project coordination role, preferably in a regulated industry (e.g., medical device, biotech, pharma)
- Understanding of FDA QSR (21 CFR Part 820), ISO 13485, or similar quality system standards
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint, Visio)
- Strong interpersonal and written communication skills
- Experience supporting cross-functional teams and/or process improvement efforts is a plus
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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DEKA Research and Development
Jul 02, 2025