Quality Documentation & Compliance Lead (Medical Devices)

4220 embecta Penel Irish Branch; Dún Laoghaire; Sur place; EUR 42 000 - 63 000; Plein temps

Résumé du poste

embecta is seeking a detail-oriented quality professional to manage batch records, drive document revisions, and maintain site documentation systems in a regulated manufacturing setting. You will work cross-functionally to support compliance, product release, and audit readiness.

The role requires a science or engineering qualification and at least 2 years in Medical Devices or Pharmaceutical manufacturing, with experience in SAP or similar QMS systems and a strong attention to detail.

Qualifications

• Excellent interpersonal and communication skills.
• The ability to work progressively as part of a team and on own initiative.
• Eager to learn and follow direction.
• Excellent attention to detail.

Responsabilités

• Review batch records for accuracy and compliance with procedures.
• Coordinate maintenance of the site's Documentation System and manage change requests.
• Maintain batch history records and related documentation.
• Record batch review results in the complaint management system.
• Prepare technical documentation including product certification for worldwide distribution.
• Support Regulatory and Customer audits as part of the site audit team.
• Provide support for the Quality Management System.

Connaissances

Interpersonal communication

Attention to detail

Teamwork

Eager to learn

Formation

Science/Engineering qualification

Outils

SAP or similar QMS

Description du poste

embecta is seeking a detail-oriented quality professional to manage batch records, drive document revisions, and maintain site documentation systems in a regulated manufacturing setting. You will work cross-functionally to support compliance, product release, and audit readiness.

The role requires a science or engineering qualification and at least 2 years in Medical Devices or Pharmaceutical manufacturing, with experience in SAP or similar QMS systems and a strong attention to detail.