Quality Management System Document Control Engineer

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.

• Responsible for controlling and issuing part numbers for newly created parts or documents and tracking the history, revision levels and status through the life of the parts/documents.
• Responsible for the maintenance of the Quality Management System (QMS) and all associated documents
• Select and develop personnel to ensure the efficient operation of the production function.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
• Ensure that document release packages are accurate, complete, and current and that all documents are maintained and controlled.
• Create, implement, and finalize engineering change orders (ECO's) and makes system changes.
• Develop and implement performance metrics
• Supports QMS Management Reviews, taking minutes and tracking actions
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Supports Compliance (ISO) and Regulatory (FDA) audits
• Serve as the document control focal point for assigned customer projects.
• Responsible for 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.
• Develop new processes to support document and configuration control requirements.
• Ensures documents are properly reviewed, updated, approved, and released to remain in control

• Regulated Industry experience medical device/pharma
• 2+ years of experience
• Experience with ISO 13485 / FDA 820
• Bachelor’s degree

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

QualityRelocation: Not eligibleNoFlex 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: [email protected].