CAPA Engineer
Bloomington, Indiana- onsite
Contract on W2
and
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.
Ayush Sharma Sr. US Technical Recruiter
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