QA Engineer (Software Validation) at Freudenberg Medical
County Leitrim, Northern Ireland, Ireland -
Full Time


Start Date

Immediate

Expiry Date

23 Aug, 25

Salary

0.0

Posted On

23 May, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Pharmaceutical Industry

Industry

Pharmaceuticals

Description

Working at Freudenberg: “We will wow your world!” This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,500 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
Some of your Benefits
Health Insurance
Flexible Work Models
Company Pension
Education Reimbursement
Cafeteria/ Canteen
Carrick-on-Shannon (Co. Leitrim)
On-Site
VistaMed Ltd.
You will support our team as:

Responsibilities
  • Key Responsibilities (including but not limited to):
  • Apply knowledge of GAMP (Good Automated Manufacturing Practice) in all relevant activities.
  • Complete software risk assessments and ensure robust documentation practices.
  • Interpret and generate key documentation including Intended Use Statements (IUS), User Requirement Specifications (URS), and Functional Specifications (FS).
  • Maintain and complete Requirements Traceability Records.
  • Develop and execute Software Validation Documentation, including Master Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Participate in New Product Introduction (NPI) programs to ensure alignment with ISO 13485 requirements for software applications.
  • Maintain the Plant Software Master Plan, ensuring it is current and audit-ready.
  • Promote and adhere to all Plant Safety Procedures, including Health & Safety (H&S) and Occupational Health & Safety (OH&S) responsibilities.
  • Actively contribute to the continuous improvement of OH&S, Environmental, and Energy Management System
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