HoverTech International, an international medical device company and a leader in the safe patient handling and movement is seeking a Quality Systems Specialist to join their team in Allentown, PA.

The Quality Systems Specialist plays a critical part in ensuring that engineering, quality, and operational documentation is maintained in compliance with ISO 13485 and FDA 21 CFR Part 820.

The ideal Quality Systems Specialist candidate has 2-4 years quality systems or document control experience within a regulated industry, has a working knowledge of ISO 13485, is familiar with FDA QSR, is organized and detail oriented.

HoverTech International offers…

• Competitive compensation
• 100% employer paid benefits (for employee and family)
• Medical, dental, vision
• 401K plan
• Life insurance
• Tuition reimbursement
• Laid-back dress code and is dog friendly! 

The Quality Systems Specialist will be responsible for:

eQMS Administration

• Serve as the primary administrator for the eQMS platform (Greenlight Guru).
• Manage document routing, review workflows, and electronic signature approvals.
• Maintain document metadata, version control, and document status within the system.

Document Control & Change Management

• Administer document change requests, change orders, and document releases.
• Ensure controlled documents follow approved templates and formatting standards.
• Maintain the lifecycle of controlled documents including creation, revision, and obsolescence.

Quality Systems Compliance

• Ensure documentation and records comply with ISO 13485, FDA 21 CFR Part 820, and Part 11.
• Maintain ALCOA+ data integrity standards across quality documentation.
• Support ongoing QMS compliance and continuous improvement initiatives.

Training Management

• Coordinate document-based training assignments within the eQMS.
• Track completion of training tied to document revisions and releases.
• Maintain accurate training records for audit readiness.

Design & Device File Management

• Support engineering teams in maintaining Design & Development Files (DDF) and Medical Device Files (MDF).
• Ensure design documentation is properly organized and maintained within the QMS.

Audit & Quality Support

• Retrieve documentation and records during internal and external audits.
• Assist with management of CAPA, Non-Conformance (NC), and quality records
• Support inspection readiness for regulatory and notified body audits.

Quality Systems Specialist Qualifications:

• 2-4 years quality systems or document control experience within a regulated industry (medical device strongly preferred).
• Must have 2+ years’ experience with an eQMS (Greenlight Guru preferred).
• Must be familiar with FDA QSR and ISO 13485.
• Excellent organizational, documentation, and communication skills.
• Must be detail oriented.