More jobs:
Quality Assurance Specialist - Medical Devices
Job in
Harleysville, Montgomery County, Pennsylvania, 19438, USA
Listed on 2026-09-07
Listing for:
Medical Components, Inc.
Full Time
position Listed on 2026-09-07
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Quality Engineering
Job Description & How to Apply Below
Quality Assurance Specialist
Full-Time | Onsite | Harleysville, PA
Position SummaryMed Comp 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.
- 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.
- 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.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×