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
Who are we:
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.
What you’ll do in this role:
The primary purpose of this position is to be responsible for maintaining all quality and related documentation in accordance with the requirements of ISO 13485, FDA CFR 21:820 and ISO 14001 standards and regulations. The Quality Documentation Clerk is responsible for the timely, accurate and efficient preparation and management of documents.
Accountabilities & Responsibilities:
- Adheres 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, company policies and operating procedures, and other regulatory requirements.
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Management and distribution of all documentation, internally or externally generated, which support Management systems:
- Processing of all Electronic Change Orders (ECO) and Change Requests (CR’s), including CR’s & change notices from corporate.
- Circulation of Galway and Chaska ECO’s and CR’s as required.
- Maintenance of new and updated Device History Records.
- Notification of new or updated Quality Management Systems (QMS) documents to relevant parties.
- Distribution and maintenance of QMS documents to personnel as required.
- Maintenance of various logs and stamps to allow the tracking of required documents.
- Processing of Rework Requests in a timely manner to facilitate continuous production flows.
- Processing of Temporary Deviations in a timely manner to facilitate continuous production flows.
- Assist with provision of documents needed to support regulatory queries and compilation of information where necessary. Assist in the preparation of all quality documentation as required.
- Provide support where needed in the quality department.
- Maintenance of quality related documentation held in Archives.
- Prepare ad-hoc reports as required.
- Provide reports as required e.g. ECO/CR reports.
- Auditing scanned Device History Records.
- Attachment of approved amended pages to Device History records as required.
- Work Order Collection from relevant departments and filing.
How you will be measured:
The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
- Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
- You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
- Quality – Achievement of site Quality KPIs
- Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.
- Living the Integer Values in your day-to-day work and in your interaction with others both inside and outside of the organisation.
Education & Experience:
- Leaving Cert or equivalent
- Secretarial/Administrative skills course
- Computer literate
Knowledge & Skills:
- Ability to communicate and work with people inside and outside the department as necessary to execute these responsibilities.
- 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 organisational skills are essential
Mental Demands:
- Attention to detail.
- Must be a well organised individual with excellent interpersonal skills
- Must have excellent time management skills
U.S. Applicants: EOE/AA Disability/Veteran
