Quality Release Associate

Job Description

Job Description

Job Summary:

The Product Release Quality Associate reports to the Quality Manager and supports finished product release. Activities include reviewing production and quality records for completeness, accuracy, and compliance before product is released to inventory, shipment, or the customer.

Essential duties and responsibilities:

• Review DHRs, shop order documentation, production travelers, inspection records, test records, labeling records, and other required release documentation in accordance with ISO 13485 and quality system requirements.
• Verify required operations, inspections, tests, signatures, dates, quantities, serial numbers, lot numbers, and traceability information are complete and accurate.
• Confirm applicable nonconformances, deviations, rework, repairs, concessions, or approvals are properly documented before release.
• Prevent or hold product release when required documentation is incomplete or unresolved quality issues exist.
• Communicate release status, documentation gaps, and release priorities to Quality, Operations, Shipping, and Customer Service.
• Maintain release logs, checklists, trackers, and product status records.
• Support reconciliation of released product against inventory, shipment, or ERP transactions.
• Identify repeat documentation issues and escalate trends to Quality leadership.
• Support improvements to DHRs, release checklists, production documentation, and release workflows.
• Assist with gathering release records for customer requests, complaints, RMAs, audits, or investigations.
• Assist with other QMS support duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position .

The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.

Education

• Bachelor’s degree or an equivalent combination of education/experience.

Experience and/or Training

• Experience reviewing DHRs, batch records, production travelers, inspection records, test records, or shop order documentation.
• Familiarity with good documentation practices, product traceability, nonconformance records, and controlled release processes.
• Experience using ERP systems, document management systems, or electronic production records.
• Preferred - Working knowledge of quality system standards (QMSR/ISO 13485).

Physical and mental demands

• Frequent – Seeing, reading, hearing, sitting, listening, decision making, comprehension, computer use, writing, and collaborating
• Intermittent – measuring, math, presenting, and lifting up to 40 lbs

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.