Quality System Specialist

Medasource; Madison (WI); On-site; USD 70,000 - 95,000; Full time

Job summary

Medasource seeks a Quality System Specialist to join our Madison, WI team, focusing on maintaining and improving the QMS in a regulated medical device setting. You'll manage document control, CAPA administration, internal audits, and support ISO 13485 and FDA quality system requirements, collaborating with cross‑functional teams to drive continual improvement and ensure regulatory readiness.

This onsite role offers exposure to Notified Body interactions, external audits, and certification

Qualifications

• Bachelor's degree in technical, scientific, quality, engineering, or related field.
• 3-5 years of Quality Assurance experience within a medical device manufacturing environment.
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• Hands-on experience with document control, CAPA, and/or internal audit processes.
• Strong documentation, organization, and attention to detail.
• Ability to work effectively with cross-functional teams in a regulated environment.
• Proficiency with Microsoft Office or similar business applications.

Responsibilities

• Prepare, review, and approve quality system documents, ensuring regulatory compliance.
• Support and administer the CAPA program and track effectiveness checks.
• Analyze and trend CAPA and audit data for Quality Management Reviews.
• Support ISO 13485, MDSAP, and MDR/IVDR requirements.
• Gather evidence and track certification timelines.
• Assist with internal and external audits and regulatory inspections.

Skills

Quality Assurance

Regulated environment

Cross-functional teamwork

Education

Bachelor's degree in related field

Tools

MS Office

eQMS

ERP systems

ComplianceQuest

Job description

Our Client is seeking a Quality System Specialist to join their Quality team in Madison, WI. This individual will work closely with the Quality System Manager to support the maintenance and continuous improvement of the organization's Quality Management System (QMS).

This role will have a strong focus on document control, CAPA administration, quality system audits, certification maintenance, and management review activities within a regulated medical device environment. The ideal candidate will have hands‑on quality assurance experience within medical device manufacturing and a strong understanding of ISO 13485 and FDA quality system requirements.

Key Responsibilities

• Prepare, review, and approve quality system documents, including procedures, work instructions, and forms, ensuring accuracy, consistency, and regulatory compliance.
• Support and administer the CAPA program, including reviewing CAPA records, evaluating root‑cause documentation and corrective/preventive action plans, tracking action items, and confirming effectiveness checks are completed.
• Analyze and trend CAPA and audit data for Quality Management Reviews.
• Support ongoing certification and recertification activities related to ISO 13485, MDSAP, and MDD/MDR requirements.
• Gather supporting evidence, prepare documentation packages, and track certification timelines.
• Support the planning and execution of the internal audit program, including audit scheduling, checklist preparation, documentation of findings, and corrective action follow‑up.
• Participate in or lead internal quality audits.
• Assist with preparation for external audits and regulatory inspections, including Notified Body/Registrar audits and FDA inspections.
• Help coordinate documentation and evidence retrieval during external audits.
• Prepare inputs for Quality Management Reviews, including quality objectives, audit results, CAPA trends, and complaint/post‑market surveillance data.
• Partner with the Quality System Manager and cross‑functional teams to identify opportunities for continuous improvement across QMS processes.

Required Qualifications

• Bachelor's degree in a technical, scientific, quality, engineering, or related field.
• 3-5 years of Quality Assurance experience within a medical device manufacturing environment.
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• Hands‑on experience with document control, CAPA, and/or internal audit processes.
• Strong documentation, organization, and attention to detail.
• Ability to work effectively with cross‑functional teams in a regulated environment.
• Proficiency with Microsoft Office or similar business applications.

Preferred Qualifications

• ASQ certification, such as CQA or CQE.
• ISO 13485 Lead Auditor or Internal Auditor certification.
• Experience supporting EU MDR and MDSAP requirements.
• Experience hosting or supporting Notified Body, Registrar, or FDA audits/inspections.
• Experience working with ERP and electronic Quality Management Systems (eQMS).
• Experience with ComplianceQuest is a plus.

This is an onsite position in Madison, Wisconsin, working within an office and light manufacturing/laboratory environment. The position may require extended periods of sitting or standing, regular computer use, and occasional lifting of up to 25 lbs.