Quality Assurance and Document Control Specialist responsible for label review, production record verification, nonconformance support, document control, training records, calibration tracking, and quality system documentation within a medical device environment. Job Requirements High school diploma or GED. Minimum 1-2 years of quality assurance or document control experience in a medical device environment. Experience working within regulated Quality Systems. Knowledge of Good Documentation Practices (GDP). Experience reviewing production records or Device History Records (DHRs). Experience with document control activities. Proficiency with word processing and spreadsheet applications. Experience maintaining electronic or hard-copy quality records. Experience supporting nonconformance documentation and disposition activities. Preferred Skills Associate degree. Experience reviewing and releasing product labels. Experience with Engineering Change Orders (ECOs). Experience with equipment calibration tracking and documentation. Experience supporting internal or external audits. Experience maintaining training records. Experience supporting management review or quality board reporting. Experience with NCR processing in a regulated manufacturing environment. Job Responsibilities Review product labels to ensure compliance with approved specifications. Release labels for manufacturing use according to production requirements. Review subassembly-level Device History Records and production documentation. Verify label and DHR requirements prior to material release. Escalate identified nonconforming product to Quality Engineering. Perform authorized rework or sorting of nonconforming product. Support execution of Nonconforming Report dispositions. Scan, file, and maintain controlled quality documents. Maintain distribution books and source document files. Upload and organize controlled documentation within applicable systems. Maintain electronic and hard-copy training records. Process Engineering Change Orders as assigned. Track equipment calibration schedules. Review and approve calibration records according to established procedures. Escalate out-of-calibration equipment to Quality Engineering. Support containment activities related to calibration issues. Support internal and external quality audits. Collect quality data for management reviews and quality board meetings.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.