Integer Holdings

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

QA Documentation Lead

JOB SUMMARY

The primary purpose of this position is to support several key processes within the Quality Management System to assure compliance to ISO 13485, FDA 21CFR:820, Medical Device Regulations (EU 2017/745) and other regulations in Integer, Galway. You will be responsible for outlining a long-term storage strategy, working with colleagues to ensure consistency of documentation practice across the company, training employees in change control, performing audits of record management, managing the temporary deviation process, tracking implementation plans, monitoring and measuring Document Control metrics, among other duties. This position will support all processes and functions at Integer Galway, including responsibility for planning and coordinating documentation associated with developing and manufacturing of products throughout its lifecycle from design to production. You will be responsible for representing the Company in a professional and exemplary manner before our customers, suppliers, associates, and community. You will ensure that Integer’s internal and external customer expectations are met or exceeded with the guidance from supervisors and managers in your organization. You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, Medical Device Regulations (MDR), company policies and operating procedures, and other regulatory requirements.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job related tasks which may not be specific to this position profile.

• 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

SKILLS AND KNOWLEDGE:

• 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

U.S. Applicants: EOE/AA Disability/Veteran