Medical Document Control Analyst

At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Document Control Analyst located in Columbia, SC.

Reporting to the Business Excellence Manager, the Document Control Analyst role involves controlling and maintaining the engineering change and documentation tracking process with emphasis on Bills of Material (BOM's), parts masters, specifications, drawings and documentation to ensure appropriate changes are documented.

What a typical day looks like:

• Creates, implements and finalizes engineering change orders (ECO's) and makes system changes.
• Performs file maintenance of BOM's, parts drawings, ECO's, process alerts and other customer documents.
• Coordinates ECO status with customer and implements cost changes and effective dates.
• Ensures projects are followed and in compliance with document control policies and procedures.
• Ensures data accuracy and completeness of documentation including logs, reports and distribution.
• Manages and tracks product configuration and manufacturing/customer requirements.
• Responsible for interface between program manager, engineering, manufacturing and materials to ensure appropriate changes are documented.
• Collects and reports process performance metrics. Track work completed by customer program for reporting purposes.

The experience we're looking to add to our team:

• Minimum of 2 years of related experience
• Proficiency in Microsoft Office (Excel, PowerPoint, Word)
• Agile
• Medical Industry knowledge and experience on: Clinical study of medical device or pharma.
• Experience preparing for external QMS and regulatory audits, audit room manager/coordinator, train and prepare staff.
• Expertise knowledge level and application of QSR's, MDR/IVDR, IVDD, EU/ISO 13485, 14971, and MDSAP
• First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements with experience in IVDR/MDR and MDSAP.
• Medical Industry Qualifications: ASQ CQE/CSQE or equivalent (preferred)

What you'll receive for the great work you provide:

• Full range of medical benefits, dental, vision
• Life Insurance
• Matching 401K
• PTO
• Tuition Reimbursement
• Employee discounts at local retailers

CR08

Job CategoryProduction Engineering

Relocation:Not eligible

Is Sponsorship Available?

No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the recruitment process. Please advise us of any accommodations you may need by e-mailing: accessibility@flex.com.