Quality Documentation Lead-Parkmore Galway
Integer Holdings Corporation
- Galway
- Permanent
- Full-time
- Implementing controls for the Integer Quality Management System (QMS) and product documentation, external standards and customer-required specifications. Develops and maintains database systems to support the QMS.
- Adhering to regulatory requirements.
- Working with colleagues to ensure consistency of documentation practice across the company.
- Taking a leadership role in training/supporting associates in the use of the Document Control/Change Management module in the EQMS
- Maintain Document Control procedures and make updates where required o Processing of change controls
- Process ERP system Requests
- Maintenance of new and updated Device History Records
- Controlling access to documents.
- Removing documents that are obsolete.
- Managing an archiving system and outlining a long-term storage strategy. o Utilizing storage software and applications for electronic filing.
- Liaising with external vendors to organize collection, scanning & return of QMS documents
- Retrieving documents upon request.
- Ensuring documentation integrity both on-site and at off-site archiving facilities
- Auditing scanned Device History Records
- Tracking and Trending of Document Control related metrics and preparing data to present/discuss at Management Review
- Tracking and closure of implementation plans for the implementation and embedding of Integer Global procedures
- Releasing approved temporary deviations and tracking expiry dates
- Supporting and contributing to achievement of site operational metrics
- Informing management of the performance of the documentation and temporary deviation processes and any need for improvement.
- Assisting with both internal and external audits.
- Actively participate (SME, Task requester, Doc reviewer) during external regulatory and customer audits
- Actively participate in 5S activities and Efficiency Improvements
- Performing internal audits as per the site internal audit program
- Support supplier audits for vendors associated with record management and other supplier audits, if required
- Monitor budget with regards costs associated with off-site storage etc
- Any other activities as requested by the Quality Systems Supervisor
- Strong interpersonal and communication skills
- Competent in preparing written communication and correspondence
- Ability to train other associates
- Ability to understand and follow appropriate Departmental policies, procedures and practices, and to understand inter-relationships of people and functions.
- Rigorous attention to detail.
- Excellent time management and organizational skills are essential
- Ability to work to deadlines on own initiative
- Working knowledge of Excel and Word
- Strive for continuous improvement
- Skilled in multitasking and prioritization
- MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
- leaving Cert or equivalent
- Computer literate
- 2-3 years working in a similar role in the medical or pharmaceutical industry
- Qualified Lead Auditor is an advantage
- Level 6 or higher qualification in Quality or Engineering is an advantage
- NPHYSICAL & MENTAL DEMANDS:
- Attention to detail.
- Must be a well-organized individual with excellent interpersonal skills
- Must have excellent time management skills Ability to work to deadlines in a busy environment