CAPA Engineer

Stellent IT LLC; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Stellent IT LLC in Bloomington, Indiana, is seeking a CAPA Engineer to lead CAPA investigations and ensure compliant resolution of quality issues onsite. The role requires minimum 3 years of CAPA management experience, familiarity with ISO 13485 and FDA QSR, and strong technical writing.

The engineer will coordinate with cross-functional teams, manage CAPA meetings, track actions, and support audits, with a focus on reducing backlog and improving CAPA execution cadence.

Qualifications

• 3 years explicit CAPA management/lead experience.
• Bachelor's degree in engineering or related field.
• Knowledge of CAPA processes, ISO 13485 and FDA QSR.
• Strong communication and teamwork.

Responsibilities

• Manage CAPA program, schedule and facilitate CAPA meetings.
• Track action items and oversee CAPA implementation.
• Ensure documentation completeness and provide metrics.
• Support audits and drive CAPA process improvements.
• Lead CAPA investigations and write-ups.

Skills

Microsoft Office

communication

teamwork

Education

Bachelor's degree in engineering or related field

Tools

TrackWise

Visio

Job description

CAPA Engineer

Bloomington, Indiana- onsite

Contract on W2

USC and Greencard

Job Summary

The CAPA Leader executes within the CAPA process to ensure the adequate resolution of quality and/or compliance issues related to the operations and quality management systems.

C: Reporting Relationships and Organizational Impact

Reports To: Quality Engineering Manager

Manager Role: Non-Manager

Regular interaction with departments, employees and management at all levels.

D: Qualifications

Education: Bachelor's degree in a technical field. Preferred: ASQ/RAB certifications, Six Sigma Green Belt.

Experience: 3+ years in quality assurance/engineering and project management.

Knowledge: CAPA process, ISO 13485, ISO 14971, 21 CFR 820.

Skills: Microsoft Office, communication, teamwork.

E: Duties and Responsibilities

Manage CAPA program, schedule and facilitate CAPA meetings, track action items, oversee CAPA implementation, ensure documentation completeness, provide metrics, support audits, and improve CAPA processes.

F-I: Physical Requirements, Hazards, Lifting and Disclaimer

Office setting. Sedentary work. Compliance with company policies required.

Overview

Hiring for a fully on-site CAPA engineer (tier 4) to reduce an unprecedentedly high number of CAPAs after two audits this year (the second audit produced 6 findings).

Role requires minimum 3 years CAPA management experience, knowledge of ISO 13485 / FDA QSR (Part 820), strong technical writing and meeting leadership; plastics/medical-device background is a plus.

Preferred tools: Microsoft Office suite; TrackWise and Visio are nice-to-haves; emphasis on clear, technical written communication.

Hiring need & reason

Team experienced two audits this year, which is atypical, and the second audit produced 6 findings, driving an increased CAPA backlog.

The business needs someone who can reduce CAPA volume quickly and manage CAPA projects end-to-end.

Goal is to onboard a contractor who can hit the ground running and lead CAPA investigations and write-ups immediately.

Expected outcome: lower CAPA backlog and improved CAPA execution cadence.

Role, level, and experience

Position is not managerial; it's an engineer-level role responsible for executing and leading CAPA projects from initiation to closure.

Minimum requirements

3 years explicit CAPA management/lead experience and a bachelor's in engineering or related field.

Desired: technical expertise, ideally medical-device experience and familiarity with plastics manufacturing (extrusion, injection molding, over-molding) as a plus.

Regulatory & quality expectations

Candidate must be comfortable with ISO 13485 and associated FDA QSR expectations (FDA updated QSR to reference ISO 13485).

Many CAPAs will be quality-systems-related; knowledge of 13485-aligned processes and documentation expectations is important.

Interview should assess candidate ability to convey a clear, technical understanding and to write technically correct CAPA documentation.

Day-to-day activities

Typical day: investigating processes, coordinating with subject-matter experts, conducting root-cause analysis, and producing CAPA write-ups.

Role requires strong meeting leadership, ability to coordinate stakeholders, collect information, and drive investigation outcomes.

Consistency expected in CAPA investigation methodology and clear, succinct written outputs.

Tools & skills

Must be proficient with Microsoft Office (Excel, PowerPoint, Outlook); TrackWise experience is a nice-to-have.

Visio experience is helpful for process flow documentation and CAPA investigations, listed as a nice-to-have.

Strong technical writing, professional communication, and concise interview responses are critical evaluation criteria.