QA Specialist, Medical Devices — Compliance & Release Expert

Medical Components, Inc.; Harleysville (PA); On-site; USD 70,000 - 100,000; Full time

Job summary

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 a delegated QA authority for DHR review and product release while supporting Change Control, CAPA, and audits. The ideal candidate has 2–5 years of QA experience in medical device manufacturing or a regulated environment, demonstrates strong analytical and communication skills, and collaborates across Production, Engineering,

Qualifications

• Bachelor's degree in a science or engineering field is required.
• 2–5 years QA experience in a medical device or regulated industry.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and QMS.
• Experience with DHR review and document control.
• Strong analytical, problem-solving, and communication skills.
• Proficiency with Microsoft Office and electronic QMS.

Responsibilities

• Review DHR and release finished products.
• Approve changes through Change Control process.
• Support CAPA, validation, and risk management activities.
• Assist internal and external audits and regulatory inspections.
• Develop and maintain quality procedures and work instructions.
• Collaborate with Production, Engineering, Regulatory Affairs, and Operations.

Skills

Analytical thinking

Problem solving

Communication skills

Education

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

Tools

MS Office

Electronic QMS

Job description

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 a delegated QA authority for DHR review and product release while supporting Change Control, CAPA, and audits. The ideal candidate has 2–5 years of QA experience in medical device manufacturing or a regulated environment, demonstrates strong analytical and communication skills, and collaborates across Production, Engineering,