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Documentation ControllerLocation: Galway, G, IE
06 - Associate, Operations Quality
Req ID: 121567
Remote Position: No
Hiring Manager: Pat Murphy
Band: 06
Region: Europe
Country: Ireland
State/Province: Galway
City: Galway
Functional Area: OPS - Operations
Career Stream: QUA - Quality
Role: Associate
SAP Short Name: ASS
Job Title: Quality Associate
Job Code: AST-OPS-QUA
Job Level: Band 06
Profile-Holding: Y
Direct/Indirect Indicator: Indirect
Summary
This position is responsible for the administration of the electronic Document Management system, in line with Corporate policies and the company's quality system procedures, including audits.
Detailed DescriptionYour day- to-day activities will include…
Liaises with Customers on all documentation issues.
Co-ordination of the Change Management Process.
Issues new and revised quality system documentation efficiently and ensure that the most current revisions are made available to all users and change records are completed correctly so as to maintain the quality system.
Monitoring of the approval process for documents and notification to approvers of document readiness through an electronic DMS.
Carries out documentation audits in accordance with the internal audit schedule or production priorities.
Record and trend all documentation deficiencies, errors etc. and provide these reports weekly to Quality Systems Engineer.
Provides training when needed, to personnel on the essential elements of the electronic documentation system.
Responds to all queries in a timely manner with accurate and complete information.
Engineering data management, revision control and BOM control.
Reviews associated production line documentation such as log books, in process check sheets etc.
Maintains systems in place to remove and control obsolete quality system documents.
Maintains and update an orderly filing, archiving and retrieval system for:
Devise Master and History documents, Drawings, Logs in the area, e.g. change request log.
Supports Quality Systems Engineer in preparation for notified or customer audits.
Record retention co-ordination.
Responsible for the co-ordination, tracking and storage of records relevant to the Department/Function, as per Celestica Records Management Program Operating Procedure
What do we expect from you?
Ability to work independently and as a member of a team in a dynamic environment.
Good communication / team skills to interface with internal customers at all levels.
Good knowledge of all Microsoft Office applications and ability to operate local quality DBMS system.
Excellent knowledge of ISO 13485 and 21 CFR 820 is essential.
Strong knowledge of NPI/ECO activity essential.
Strong attention to detail and organization skills.
Good presentation skills to conduct training and presentations.
Typical ExperienceWhat are we looking for?
2-3 years' experience in a similar role.
Second Level Qualification or equivalent or experience in a quality systems administration area.
Experience in working in a medical device environment would be a distinct advantage.
Knowledge of Quality Management Systems is desirable.
Medical Device Manufacturing environment experience is desirable.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) enables the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
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