Document Control Administrator

at  Freudenberg Medical

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.

EDUCATION REIMBURSEMENT

Education Reimbursement: Receive financial aid to help propel your career to the next level.
Spiddal, Co. Galway
On-Site
Cambus Teoranta
You support our team as

QUALIFICATIONS

• Diploma qualification in Quality or a related discipline or significant relevant experience in a quality systems role within the Medical Device Industry.
• Thorough knowledge of medical devices quality systems and associated regulatory requirements (ISO 13485, FDA etc.)
• A minimum of 3 years’ experience in a similar Quality related role in the Medical Device industry.
• Experience working with eQMS, SAP and Assent systems a distinct advantage. Excellent attention to detail.
• Good communication skills both verbal and written. Fluent English skills required.
• Self-directed and results driven team player.
• Ability to work on own initiative to achieve deadlines while also capable of working as part of a multi discipline team.
• A positive attitude in dealing with people.
• Ability to learn and adapt to various situations.
  The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

• Support the administration and maintenance of the eQMS.
• Support the Quality related modules in eQMS (e.g. documentation, training, change control etc.)
• Act as the Quality Subject Matter Expert (SME) for eQMS within the organisation.
• Deliver eQMS related trainings.
• Support the administration and maintenance of the SAP System in terms of change control and the Quality related modules.
• Assist with the Assent Portal implementation and act as the Quality Subject Matter Expert (SME) for Assent within the organisation.
• Deliver Assent related trainings.
• Own and manage the various components of the current operational Quality Management System.
• Provide support for the Document Control and Record Control activities.
• Generation of reports for data trending and analysis of the quality system.
• Aid in generation of management review metrics as required.
• Knowledge and adherence to regulatory standards including ISO 13485, ISO 14971.
• Complete internal audits and assist in preparation for external, supplier and regulatory audits and audit follow up activities.
• Compliance to applicable regulatory standards and current GMP procedures and practices.
• Initiate and process Engineering Change Orders for document release and update.
• Actively participate in continuous process improvement initiatives.
• Escalate potential deficiencies to ensure timely resolution.
• Participate in training events to continuously develop and maintain competencies.
• Respond to non-standard requests from customers and suppliers.
• Support quality system compliance activities and follow up to ensure satisfactory closure of identified gaps.
• To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.