Document Controller Job Description
Sanmina Fermoy's facility is FDA registered and certified to ISO standards for the manufacture of high-quality PCBAs, subassemblies, and complete devices.
Job Objectives:
* Ensure compliance with internal standards, external standards, operating procedures, and requirements by administering company change control procedures.
* Develop and maintain effective documentation systems and procedures.
Responsibilities:
1. Administer Company change control procedures to ensure changes to official documents comply with regulatory requirements and are approved prior to use.
2. Maintain master documentation (softcopy & hardcopy) such as Standard Operating Procedures, Protocols & Validations, Forms, Labels, etc.
3. Assure the availability of current revision documents for use within the plant.
4. Evaluate performance based on predetermined standards of performance agreed upon with the supervisor.
Requirements:
* 1-2 years Document Control or related experience.
* Familiarity with ISO and FDA Quality Systems Regulations and international quality system standards.
* Proficiency in Microsoft Office Suite applications (Word, Excel, PowerPoint).
Additional Requirements:
* Medical Device Industry Experience
* Experience with company-wide Change Management System (Agile)
About Sanmina Fermoy
Sanmina Fermoy provides services for the entire product lifecycle from New Product Introduction (NPI), prototyping, and process validation to complex volume manufacturing & test, shipping, and repair. Our highly experienced workforce has a 30-year track record of outstanding operational performance and customer service.