Supplier Quality – eQMS Specialist

Milliken & Company

. Manage the supplier quality program across OVIK Health locations, ensuring risk evaluations, audits, quality agreements, and annual performance reviews are completed .

Posted 11/9/2026full-timeSalisbury • Massachusetts • United StatesMid-LevelSenior💰 $25 - $43 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing supplier quality programs, including risk evaluations, audits, and quality agreements, while ensuring compliance with ISO 13485 and FDA Quality System Regulations. Proficient in quality management systems and capable of conducting quality release testing and batch record reviews.

Highest-signal resume keywords

Supplier Quality ManagementISO 13485 KnowledgeFDA Quality System RegulationQuality Management System ImplementationMedical Device Manufacturing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AuditsBatch Release ActivitiesCAPA MonitoringQuality System Documentation ControlQuality InspectionDevice History Record ReviewsRisk EvaluationsCorrective Action RequestsQuality Training DevelopmentSterility Program Support

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationSelf-StarterTeam CollaborationDecision Making

Tools & Technologies

Greenlight Guru Electronic Quality Management SystemMicrosoft WordMicrosoft ExcelMicrosoft OutlookMicrosoft PowerPoint

Industry Keywords

Medical Device ManufacturingQuality Management SystemSupplier Quality ProgramQuality AgreementsCustomer FeedbackNonconformance ManagementInspection and Testing SystemsCotton Dust Environment ComplianceLatex Manufacturing Environment ComplianceSafety-Sensitive Manufacturing

About the role

Key responsibilities & impact

Manage the supplier quality program across OVIK Health locations, ensuring risk evaluations, audits, quality agreements, and annual performance reviews are completed
Act as the primary Quality Point of Contact for critical suppliers
Manage supplier deviations, approvals, and corrective action requests
Manage and execute batch release activities for contract manufacturers
Support the sterility program, including quarterly dose audits, annual review, and dose mapping
Support the effectiveness of the division’s quality management system
Participate in Management Review and conduct quality release testing as needed
Assist with implementation and maintenance of a Quality System based on ISO 13485 and FDA Quality System Regulation
Control quality-system documentation for Salisbury, Portsmouth, and division-wide documents
Serve as subject matter expert for the Greenlight Guru electronic Quality Management System
Monitor CAPAs, Customer Feedback, and Nonconformances
Identify quality issues and communicate them to management
Maintain quality-system procedures and controlled documents
Assist in developing and maintaining quality-system training
Assist in implementing inspection, measurement, and testing systems
Track and report significant quality deviations
Conduct Batch Record/Device History Record reviews, including sterile records
Assist with quality inspection and product-release programs throughout production
Participate in new product development to ensure quality assurance and control plans are ready before manufacturing
Participate in internal, external, supplier, and FDA audits

Requirements

What you’ll need

High school diploma
Strong verbal and written communication skills
Excellent Microsoft Word/Excel/Outlook/PowerPoint skills
Ability to work in a fast-paced work environment
Self-starting and ability to work within a team environment
Willing to travel to Headquarters in Spartanburg SC, to OVIK Health manufacturing locations, and to OVIK Health’s Supplier locations as needed
Ability to stand while working 50% of day
Ability to sit down 50% of day
Ability to move through the plant 90% of day
Ability to lift up to 25 lbs 15% of day
Ability to walk upstairs and climb to top of range (approx. 16 ft) 10% of day
Ability to push/pull fabric rolls and A-frames (approx. 1500 lbs) 10% of day
Ability to pick up objects from the floor 25% of day
Visual acuity adequate to perform job duties, including reading printed sources and computer screens
Able to make decisions, reason, and understand information
Ability to work in cotton dust environment and meet cotton pulmonary function requirements
Ability to work in latex manufacturing environment
Safety-sensitive manufacturing-facility work around moving mechanical parts and powered industrial vehicles
ISO 13485 and FDA Quality systems knowledge preferred
Medical Device manufacturing experience preferred
English and Spanish language proficiency preferred