Document Controller

About Sanmina Fermoy

Located in Fermoy, County Cork, Ireland, Sanmina's Fermoy facility is FDA registered and ISO 13485:2016 certified, specializing in manufacturing high-quality Printed Circuit Board Assemblies (PCBAs), subassemblies, and complete devices including Class III medical devices. The site emphasizes manufacturing automation and supports the complete product lifecycle from New Product Introduction (NPI) through prototyping, process validation, volume manufacturing, testing, shipping, and repair. Celebrating over 30 years of exceptional operational excellence and customer service, this facility benefits from a highly skilled and experienced workforce.

Position Overview

The Document Controller plays a key role in managing and administering all documentation to guarantee compliance with both internal and external quality standards, regulations, and procedures within the company.

Key Responsibilities

• Manage the company’s change control protocols ensuring all document modifications meet regulatory approvals prior to implementation using the Agile system.
• Develop and uphold efficient documentation systems and procedures, maintaining master documents like Standard Operating Procedures, Protocols, Validations, Forms, and Labels in both digital and physical formats.
• Ensure availability of the current and correct document revisions throughout the plant.
• Properly file, store, and retrieve quality records complying with retention policies and procedures.
• Maintain and update indexes and logs such as the Document Control Log as needed.
• Provide training on document control and change management systems to company employees.
• Support preparation and participation in external quality audits.
• Generate, manage, and distribute required reports accurately and on time.
• Collaborate actively with cross-functional quality teams to suggest and implement improvements in documentation.
• Adhere to all company policies, safety rules, and regulatory requirements.
• Take on other duties assigned by supervisors as necessary.
• Maintain ongoing compliance with industry and quality regulatory standards.
• Ensure compliance with Health & Safety legislation and regulations.

Performance Measurement

Performance will be assessed against predetermined standards agreed with supervisors, focusing primarily on the efficiency and adherence of documentation control practices.

Candidate Profile

• One to two years of experience in document control or a related function.
• Understanding of ISO standards and FDA Quality System Regulations as well as other international quality system standards.
• Fluency with computer applications and database software, particularly Microsoft Office Suite tools including Excel, Word, PowerPoint, and Google applications.
• Strong problem-solving capabilities to identify and implement solutions for documentation-related challenges.
• Effective teamwork skills.
• Excellent command of English, both written and spoken, with precise use of spelling, grammar, and punctuation and ability to communicate effectively at senior levels.
• Exceptional organizational aptitude, able to manage multiple tasks and prioritize projects aligned to business needs.
• Motivated and autonomous with minimal supervision needed once objectives are clear.
• Delivers quality outcomes within reasonable timeframes.

Preferred Qualifications

• Exposure to the medical device industry.
• Experience with company-wide Change Management Systems such as Agile.
• Ability to prioritize workload effectively and manage it independently.
• High attention to detail and ability to work proactively.
• Strong analytical skills to define problems, collect data, analyze facts, and make sound conclusions.