Quality Assurance Specialist - Medical Devices

Quality Assurance SpecialistFull-Time Onsite Harleysville, PAPosition 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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Skills:

Analysis Skills, Auditing, Biology, Certified Quality Engineer (CQE), Change Control, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Detail Oriented, Documentation, Documentation Review, FDA (Food and Drug Administration), Functional Analysis, ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Manufacturing, Medical Equipment, Microsoft Office, Operational Support, Problem Solving Skills, Process Improvement, Product Reviews, Quality Assurance, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Risk Analysis, Risk Management, Root Cause Analysis, Six Sigma, Systems Analysis, Team Player, Validation Documentation, Vendor/Supplier Quality Management



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Medical Components, Inc.