Quality Systems Engineer: CAPA & Compliance

Medartis Inc. - United States; Warsaw (IN); On-site; USD 75,000 - 110,000; Full time

Job summary

Medartis Inc. in the United States seeks a Quality Systems Engineer to strengthen its QMS and drive compliance across CAPA, audits, and process improvements.

You will partner with cross-functional teams to ensure ISO 13485:2016 and FDA 21 CFR 820 alignment, while advancing metrics and documentation. The role focuses on CAPA administration, external and internal audits, and maintaining robust document controls.

Qualifications

• BS in Engineering or related field preferred, or equivalent in experience and training.
• Working knowledge of the medical device regulated industry, to include ISO 13485 and FDA 21CFR820 regulations
• Basic knowledge of statistical and engineering principals
• Strong analytical and problem solving skills
• Strong proficiency in root cause analysis to include tools and methodology
• Proficient in Microsoft Office applications

Responsibilities

• Act as CAPA administrator by initiating CAPAs, overseeing timelines, managing the CAPA log, reporting CAPA metrics and leading CAPA review meetings.
• Manage external audit activities including certification audits and customer audits, liaising with external parties and scheduling audits.
• Facilitate all internal audit activities, including planning, assigning resources, managing the internal audit schedule, and reporting metrics.
• Gather and manage KPI/metric data used to measure the QMS.
• Assist quality management representative (QMR) in conducting annual quality management reviews per ISO 13485:2016.
• Create and/or update procedures and work instructions to capture improvements to the quality management system processes.
• Assist subject matter experts in the development, authoring and releasing of procedures and work instructions used to define their processes.
• Understand, utilize and assist in maintaining document controls and change controls within the QMS.
• Ensure processes and documentation comply with quality system regulations.

Skills

CAPA administration

Audit management

QMS

ISO 13485 knowledge

FDA 21 CFR 820 knowledge

Root cause analysis

Problem solving

MS Office proficiency

Education

BS in Engineering or related field

Tools

MS Office Suite

Job description

Medartis Inc. in the United States seeks a Quality Systems Engineer to strengthen its QMS and drive compliance across CAPA, audits, and process improvements.

You will partner with cross-functional teams to ensure ISO 13485:2016 and FDA 21 CFR 820 alignment, while advancing metrics and documentation. The role focuses on CAPA administration, external and internal audits, and maintaining robust document controls.