Quality Systems Coordinator

4220 embecta Penel Irish Branch; Dún Laoghaire; On-site; EUR 42,000 - 63,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Interpersonal communication

Attention to detail

Teamwork

Eager to learn

Education

Science/Engineering qualification

Tools

SAP or similar QMS

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world. An excellent opportunity for a detail-oriented quality professional with document control experience to manage batch records, drive document revisions, and maintain site documentation systems. You'll work cross-functionally to support compliance, product release, and audit readiness in a highly regulated manufacturing setting.

Responsibilities

• Work with cross-functional teams to support product release.
• Perform timely review of batch records and associated documentation to ensure accuracy and compliance with approved procedures.
• Track batch record review metrics and support continuous improvement initiatives.
• Be a key part of the coordination and maintenance of the site's Documentation System leading document change requests and supporting stakeholders through the document revision process.
• Maintain all batch history records and related documentation.
• Record and maintain batch record review results in the complaint management system, ensuring quality events are appropriately documented and tracked.
• Prepare technical documentation including product certification to support worldwide product distribution.
• Be a key member of the site audit team, supporting all Regulatory and Customer audits.
• Provide support for the Quality Management System as determined necessary by Quality Management.

Educational Requirements and Relevant Experience

• Science/Engineering qualification
• A minimum of 2 years experience working in Medical Devices or Pharmaceutical manufacturing environment.
• Experience working within an established Quality System
• Experience with electronic Quality Management Systems including Batch Control and Document Control ideally with SAP or similar experience.

Knowledge, Skills and Abilities

• 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

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embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At embecta, a career is more than a job, it is an opportunity to make a meaningful difference in the lives of about 30 million people around the world who depend on our products to manage a chronic condition every single day. As we expand our capabilities, reach, and impact, there's never been a more exciting time to join us.

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