Quality Coordinator

Brief Description

Reporting to the Quality Manager, the Quality Coordinator provides administrative, coordination, and documentation support to the Quality team. This role focuses on standardizing and maintaining quality records, trackers, and supporting documentation to improve consistency, reduce rework, and free Quality Engineers to focus on engineering judgment, corrective and preventive actions, and customer-facing quality decisions.

The Quality Coordinator plays a key role in supporting compliance with customer and regulatory requirements by ensuring quality documentation is accurate, complete, current, and well-organized, while escalating items that require engineering review.

Responsibilities

• Support Quality Engineers by preparing, organizing, formatting, and maintaining quality documentation related to PPAP, FAI, control plans, New Product Initiation, and supporting records.
• Perform administrative review of documents (completeness, formatting, accuracy to approved sources) prior to Quality Engineer approval.
• Maintain accurate and complete quality records in accordance with Good Documentation Practices (GDP), including version control, traceability, and proper record retention.
• Support compliance with applicable SOPs and regulatory requirements by verifying documentation reflects approved processes and escalating discrepancies to Quality Engineers.
• Maintain customer specification libraries, photo libraries, cosmetic references, and related quality resources to ensure current and consistent access across the organization.
• Coordinate RMA administrative activities, including intake documentation, part counts, tracking, and internal status updates.
• Provide clerical and coordination support for Nonconforming Product (NC) processing, including documentation, routing, sorting, and tracker maintenance, while ensuring engineering disposition decisions are completed by authorized personnel.
• Assist with ECR administration by verifying completeness, routing documentation, and maintaining ECR trackers.
• Maintain and update quality-related trackers for PPAPs, RMAs, ECRs, NCs, and other quality activities to improve visibility and consistency.
• Assist with the preparation and organization of materials for internal, customer, and third-party audits by assembling records, trackers, and supporting documentation as directed by the Quality team.
• Assist in the preparation, formatting, and review of quality documentation such as test summaries, technical reports, design support documentation, and process documentation, ensuring clarity and document control compliance (no technical approval responsibility).
• Support NPI and product launch activities through documentation preparation, checklist tracking, and coordination with Quality Engineers, MQEs, and other cross-functional teams.
• Serve as a coordination point for internal quality status requests, ensuring accurate information is provided and issues are escalated appropriately.
• Assist in preparation for internal, customer, and third-party audits by organizing records and supporting documentation as directed.
• Collaborate with Inspectors, MQEs, Quality Engineers, Manufacturing, and other departments to support smooth workflow and clear handoffs.
• Maintain organized digital and physical filing systems in alignment with Quality Management System requirements.
• Perform other duties as assigned.
  
  

Requirements

• High level of accuracy and attention to detail when preparing, reviewing, and maintaining quality documentation and records.
• Strong organizational skills with the ability to manage multiple tasks, trackers, and deadlines in a fast-paced manufacturing environment.
• Ability to follow documented procedures, Standard Operating Procedures (SOPs), and regulatory requirements, and to recognize when issues require escalation to Quality Engineering or management.
• Working knowledge of Good Documentation Practices (GDP) and the importance of accurate, complete, and traceable records in a regulated manufacturing environment.
• Clear verbal and written communication skills to document information accurately, support internal coordination, and collaborate effectively with Quality Engineers, inspectors, manufacturing, and cross-functional teams.
• Ability to work effectively as part of a team, taking direction from Quality Engineers while proactively supporting documentation flow and administrative needs.
• Strong prioritization skills, with the ability to meet deadlines while maintaining documentation accuracy and compliance.
• Proficiency with Microsoft Office applications (Excel, Word, Outlook) and comfort working with document control systems, SharePoint, ERP systems, and quality tracking tools.
• Attention to consistency and standardization to reduce rework, improve document quality, and support audit readiness.
• Comfort working in a regulated environment with an understanding of basic FDA, ISO 13485, and GMP documentation expectations (administrative support role; no engineering approval responsibility).
  
  

Education And Work Experience Required

• Associate degree or equivalent in Quality, Manufacturing, Engineering technology, Business Administration, or a related field preferred.
• 2 years of experience in a quality, manufacturing support, documentation, or administrative role within a regulated or precision manufacturing environment preferred.
• Experience supporting quality documentation such as PPAPs, FIRST ARTICLE inspections, control plans, inspection records, DMR/DHR documentation, or similar regulated records preferred.
• Working knowledge of documentation expectations under ISO 13485, FDA 21 CFR 820 (QMSR), or comparable regulated quality systems preferred.
• Experience working with document control systems, ERP systems (Epicor or similar), SharePoint, and/or quality tracking tools preferred.
• Demonstrated ability to work effectively with engineers, inspectors, and manufacturing personnel while maintaining clear role boundaries and appropriate escalation to engineering or quality leadership.