Document Controller

Sanmina-SCI Systems de México; Fermoy; On-site; EUR 30,000 - 42,000; Full time

Job summary

Sanmina Fermoy in Fermoy, Ireland, seeks a Document Controller to manage company documentation and ensure compliance with ISO and FDA quality standards. The role supports change control, audit readiness, and cross-functional collaboration within a manufacturing quality environment.

The successful candidate will have 1–2 years in document control, strong English communication, and proficiency in MS Office. Partners with a safety-conscious, team-oriented culture in a GMP setting.

Qualifications

• 1-2 years document control or related experience.
• Familiarity with ISO and FDA Quality Systems Regulations and international quality standards.
• Proficiency with PC and database software, including Microsoft Office Suite (Google, Excel, Word and PowerPoint).
• Strong problem solving and teamwork abilities.

Responsibilities

• Administers change control procedures to ensure regulatory-compliant document changes and approvals.
• Maintains master documentation (soft/hard copy) including SOPs, protocols, validations, forms and labels.
• Ensures current revision documents are available for use in the plant.
• Filenames/records stored and retrieved per retention policies.
• Trains staff on document control and change control processes.
• Supports external audits preparation and execution.
• Generates, manages, and distributes reports as required.
• Contributes to quality teams and cross-functional documentation improvements.
• Ensures compliance with company policies and safety regulations.

Skills

Document Control

MS Office

English communication

Teamwork

Tools

Microsoft Office

Job description

Job Title: Document Controller

Department: Quality Department

Reporting To: Quality Lead

About Sanmina Fermoy

Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.

Sanmina Fermoy’s core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.

We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few.

Objectives of Position

The administration/control of documents in order to ensure that the Company maintains compliance with internal standards, external standards, operating procedures and requirements.

Responsibilities

• Administers Company change control procedures to assure that changes to all official documents comply with regulatory requirements and are approved prior to use - Usage of Agile.
• The development and maintenance of effective documentation systems and procedures. Maintaining master documentation (softcopy & hardcopy) such as Standard Operating Procedures, Protocols & Validations, Forms, Labels, etc.
• Assure the availability of the current revision documents for use within the plant.
• Ensure that quality records are filed/stored and retrieved in accordance with record retention policy /procedures
• Maintain various indexes and logs (e.g., Document Control Log) and update as required.
• Trains other Company employees in the document control and change control systems as required.
• Assist if and when necessary in the preparation for and during external audits.
• Generation, management and distribution of reports as required
• Plays an active role on quality teams within the organization and works with cross functional groups to identify and implement documentation changes and improvements.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Other duties as assigned by manager/supervisor
• Assure ongoing compliance with quality and industry regulatory requirements
• Ensure compliance with Health & Safety Legislation and Regulations.

Measurements

• Performance will be evaluated with reference to the predetermined standards of performance as agreed upon with the position’s supervisor. Predominantly the appraisal shall relate to the overall performance of Documentation Control Area and Documentation Control Practices.

Personnel Specifications

Essential

• 1-2 years Document Control or other related experience.
• Familiarity with ISO and FDA Quality Systems Regulations and international quality system standards.
• Proficiency in the use of personal computers and computer database software, including Microsoft Office Suite applications (Google, Excel, Word and PowerPoint).
• Employs problems solving skills to identify alternative solutions, project consequences of proposed actions, and implement recommendations in support of goals to resolve documentation system related issues.
• Works effectively in a Team environment.
• Excellent written and verbal communication skills. Proficient in English usage, spelling, grammar and punctuation. Ability to effectively present information to top management.
• Exceptional organizational skills. Capable of managing multiple jobs and prioritizing projects based on needs of the business.
• Self motivated and self-directed. Requires minimal guidance once clear goals and responsibilities are established.
• Produces quality work in a reasonable timeframe.

Desirable

• Medical Device Industry Experience
• Experience with company-wide Change Management System (Agile)
• Ability to prioritize and manage the workload as required
• Ability to work on own initiative and a high level of attention to detail
• Ability to define problems, collect data, establish facts, and draw valid conclusions.