Quality Systems Specialist

deka; Richmond (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

DEKA Research & Development is seeking a Quality Systems Specialist to advance our medical device QMS in a high-visibility role reporting to the Director of Quality. The position focuses on document control, records, DCNs, and training within a regulated environment.

You will implement and maintain QMS procedures, support audits, and promote QMS awareness across DEKA. A degree in engineering or science or 5+ years in QMS is preferred.

Qualifications

• 2+ years’ experience in a QMS or document-centric environment, degree in Engineering or Science, or 5+ years in QMS without a degree.
• Understanding and working knowledge of ISO 13485 and Quality System regulations is required.
• Proficient in using eQMS systems; experience validating eQMS systems is preferred.
• Experience with documentation in a regulated field such as medical devices.

Responsibilities

• Manage documents, records, DCN, and training processes.
• Review and approve Quality System Records.
• Collaborate with Quality Systems Manager to implement an eQMS.
• Create, implement, and maintain quality system documents; manage changes and distribution.
• Ensure document accuracy, quality, and integrity.
• Process changes for QMS Procedures (SOPs) and track DCNs to approval signatories.
• Support updating procedures and processes to support the QMS.
• File and maintain records manually and electronically.
• Monitor metrics for document management and training efficiency.
• Manage QMS databases for action items and implementation.
• Support external and internal audits.
• Provide training to DEKA personnel as required.
• Promote QMS awareness across DEKA.

Skills

QMS

Documentation

ISO 13485

eQMS

Auditing

Microsoft Office

Communication

Learning ability

Education

Engineering or Science degree

5+ years QMS without degree

Job description

DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialist to work in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. This is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:

• Responsible for documents, records, DCN, and Training processes
• Review and Approve Quality System Records
• Works closely with the Quality Systems Manager to implement an eQMS system
• Create, implement, and maintain existing quality system documentation and manage changes to process/product documents, including format and numbering, record retention, change control and document distribution
• Ensure document accuracy, quality, and integrity
• Process changes for QMSProcedures (SOPs)
  • Make red-line changes
  • Process DCNs to approval signatories
  • Make new master documents, archive and distribute via electronic system
  • Track training for QMS documents within the Change Order process
  • Track open impacts to completion
• Support updating procedures and processes to support the QMS
• File and maintain records manually and electronically
• Establish, monitor, and respond to metrics on the efficiency of the document management and training processes and its ability to support the business
• Manage QMS databases for action items and implementation
• Support external and internal audits
• Provide training as required to DEKA personnel
• Promote QMS awareness to non-QA departments throughout DEKA

Skills needed to be successful:

• 2+ years’ experience in QMS or document centric environment with degree in Engineering or Science degree/background or 5+ years’ QMS or document centric environment without degree
• Understanding and working knowledge of ISO 13485 and Quality System regulation is required
• Proficient in the use of eQMS systems; experience validating eQMS system is preferred
• Experience with documentation in a regulated field such as medical device
• Prior auditing experience is a plus
• Strong written/verbal communication skills
• Strong computer skills, including Microsoft Office applications (i.e., Word, Excel, PowerPoint) and Adobe Acrobat.
• Ability to:
  • Learn custom software programs
  • Multitask and carry tasks through to completion
  • Manage multiple sources of data and develop reports

About Millyard Advanced Medical Products:

https://millyardadvanced.com/

Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.

Selected Partners:

• Contract Designer: DEKA Research & Development
• Contract Manufacturer: Merrimack Manufacturing

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.