Quality Specialist - Medical Device Combination Products

Role Overview

The Medical Device Combination Product Specialist will provide quality-centric support and oversight throughout the lifecycle of combination products. Key responsibilities include managing change control, CAPA processes, and quality management system (QMS) records. This position serves as a communication bridge between various quality functions including Medical Device Quality, QC, Operations Quality, Central Quality, Supplier Quality, and Contract Manufacturing Organizations (CMOs), facilitating compliance and decision-making.

Key Duties

• Assist the Medical Device Quality Team in updating and releasing documents and records within the document management system.
• Support audit preparedness activities related to combination products and provide assistance during audits.
• Provide support for inspections and compliance relating to Notified Body and Health Authority requirements.
• Collect, collate, and analyze QMS data to aid in periodic Combination Product Management Review reports, meetings, and follow-up actions.
• Contribute to weekly, monthly, and quarterly QMS governance reporting.
• Support cross-functional teams by facilitating review board meetings such as Change Control, Supplier Change, planning, Standards review, and risk assessment, while updating Supplier Quality Agreements.
• Coordinate review meetings including documenting minutes, recording actions, and proper filing of records.
• Ensure timely entry, processing, and closure of quality records in alignment with company procedures.
• Engage in site team meetings on operations activities to assure quality compliance specific to combination products.
• Provide compliance oversight within Deviation and CAPA processes, guide CAPA owners through initiation and completion of actions according to SOPs.
• Assist change control initiators in preparing documentation that complies with combination product regulations; ensure documentation and impact assessments are adequate for Change Control Review Board approval.
• Collaborate with external partners such as device constituent manufacturers to address investigation outcomes and root cause analyses.
• Work with Quality partners to maintain and improve the combination product Quality Management System.
• Communicate clearly and effectively, both orally and in writing, across internal departments and with external partners.
• Adhere to company quality assurance standards and applicable regulatory requirements.

Required Qualifications

• Bachelor's degree or relevant equivalent experience in a regulated environment.
• Familiarity with medical device and/or combination product regulatory frameworks such as FDA QMS Regulation (21 CFR Part 820 and Part 4), ISO 13485, EU Regulation 2017/745, and ISO 14971.
• Proficiency with electronic QMS/document management platforms like Veeva Vault for document lifecycle and tracking quality events and actions.
• Experience managing compliance or quality projects in a regulated medical device or combination product context.
• Capability to plan, monitor, and execute projects while focusing on quality, compliance, and deadlines.
• Experience in applying risk-based continuous improvement approaches within a Quality Management System.

Preferred Experience

• Technical knowledge of quality systems is advantageous.
• At least 4 years of current Good Manufacturing Practice (cGMP) experience in quality roles within medical device, combination product R&D, or manufacturing sectors.
• Knowledge of Six Sigma methodology, ideally Green Belt certified.