Quality Assurance Specialist - Medical Devices

Medical Components, Inc.; Harleysville (PA); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

Medical Components, Inc. is seeking a Quality Assurance Specialist to support our QMS and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP.

The role acts as the delegated QA authority for DHR review and product release, while supporting CAPA, Change Control, validation, and internal audits. The ideal candidate will be detail-oriented, with 2–5 years of QA experience in medical device manufacturing or a regulated field, and strong analytical and communication skills to thrive in a

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.

Responsabilités

• Review DHR and supporting documentation to ensure compliance with product specifications and quality requirements.

Connaissances

QA

Regulatory knowledge

DHR review

Analytical thinking

Communication

Formation

Bachelor's degree in Engineering or Life Sciences

Outils

Microsoft Office

eQMS

Description du poste

Quality Assurance Specialist

Full-Time | Onsite | Harleysville, PA

Position Summary

MedComp is seeking a Quality Assurance Specialist to support our Quality Management System (QMS) and ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and internal quality requirements. The role serves as a delegated Quality Assurance authority for Device History Record (DHR) review and product release activities while supporting Change Control, Validation Review, CAPA, and Quality System compliance.

The ideal candidate is a detail-oriented quality professional with experience in medical device manufacturing or another regulated industry who thrives in a collaborative, fast-paced environment.

Key Responsibilities

• Review DHR and supporting documentation to ensure compliance with product specifications and quality requirements.
• Provide final QA disposition and release of finished products.
• Review and approve product, process, and quality system changes through the Change Control process.
• Evaluate validation documentation, risk assessments, and supporting recrods for adequacy and compliance.
• Support investigations, nonconformances, root cause analysis, and CAPA.
• Assess Quality System changes and coordinate cross-functional impact assessments.
• Support supplier quality activities, including supplier corrective actions and investigations.
• Monitor quality metrics and trends and recommend process improvements.
• Assist with internal audits, customer audits, and regulatory inspections.
• Develop and maintain quality procedures, work instructions, and related documentation.
• Partner with Production, Engineering, Regulatory Affairs, and Operations to support compliance and continuous improvement initiatives.

Qualifications

Required

• Bachelor's degree in Engineering, Life Sciences, or a related field, or an equivalent combination of education and experience.
• 2-5 years of Quality Assurance experience in a medical device manufacturing environment or other regulated industry.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and QMS
• Experience with DHR review, document review, investigations, or quality system processes.
• Strong analytical, problem-solving, and communication skills.
• Proficiency with Microsoft Office and electronic QMS.

Preferred

• Experience with Change Control, CAPA, Validation, Risk Management, and Supplier Quality processes.
• Experience supporting regulatory inspections and audits.
• CQA, CQE, Six Sigma, or similar certification.
• ISO 13485 Lead Auditor certification.