Quality Systems Specialist

DEKA Research & Development; Manchester (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

DEKA Research & Development in Manchester, NH, seeks a Quality Systems Specialist to maintain and improve the quality management system in a dynamic medical device R&D setting. This high visibility role reports to the Director of Quality and directly impacts quality records and training.

You will manage documents, DCNs, SOPs, and change control, implement an eQMS system, and ensure accuracy and traceability across the QMS.

Qualifications

• 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, carry tasks through to completion, manage multiple data sources, and develop reports.

Responsibilities

• Responsible for documents, records, DCN, and Training processes
• Review and Approve Quality System Records
• Work 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

QMS experience

ISO 13485 knowledge

eQMS proficiency

Medical device documentation

Auditing experience

Communication skills

Computer skills

Multitasking

Reporting & analytics

Education

Engineering or Science degree/background

5+ years’ QMS experience without degree

Tools

eQMS system

Microsoft Office

Adobe Acrobat

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.