Quality Assurance SpecialistFull-Time | Onsite | Harleysville, PA
Position SummaryMedComp 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.
QualificationsRequired- 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.
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