CAPA Quality Engineer for Regulatory Excellence

Siemens Healthineers in; Hoffman Estates (IL); On-site; USD 98,000 - 135,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Job summary

Siemens Healthineers in Hoffman Estates, IL is seeking a Quality Engineer to manage CAPA programs. You will lead end-to-end CAPA, drive investigations, and ensure compliance with ISO 13485 and FDA regulations.

You’ll collaborate across engineering, manufacturing, supply chain and regulatory teams, maintain QMS records, train staff, and support audits. Base pay ranges from $98,140 to $134,937, with eligibility for commissions depending on plan.

Qualifications

• Bachelor's degree in engineering or quality management.
• 2+ years in quality engineering or related role.
• Experience managing CAPA in regulated industries.
• Familiar with ISO 13485 and 21 CFR Part 820.
• Strong CAPA, RCA, and quality-tools knowledge.
• Excellent problem-solving and analytical skills.
• Proficient with QMS software (CATSweb, MasterControl, TrackWise).
• Strong communication and cross-functional collaboration.
• Detail-oriented with focus on compliance and documentation.

Responsibilities

• Lead end-to-end CAPA process from identification to effectiveness verification.
• Facilitate cross-functional CAPA board meetings and track actions.
• Design and maintain CAPA processes aligning with ISO 13485, MDSAP, FDA.
• Use quality tools (5 Whys, Fishbone, FMEA) to identify root causes.
• Ensure CAPA docs meet regulatory/audit requirements.
• Collaborate with engineering, manufacturing, supply chain, and regulatory teams.
• Train staff on CAPA processes and promote a culture of quality.
• Administer CAPA software and manage user accounts.
• Monitor CAPA metrics, prepare reports, present to leadership.
• Support internal/external audits as SME; conduct internal audits for Molecular Imaging.

Skills

CAPA processes

Root cause analysis

Quality management systems

Regulatory compliance

Cross-functional collaboration

Analytical skills

Documentation

QMS software

Education

Bachelor's degree in engineering or related field

ASQ CQE or Six Sigma (preferred)

Tools

CATSweb

MasterControl

TrackWise

Job description

Siemens Healthineers in Hoffman Estates, IL is seeking a Quality Engineer to manage CAPA programs. You will lead end-to-end CAPA, drive investigations, and ensure compliance with ISO 13485 and FDA regulations.

You’ll collaborate across engineering, manufacturing, supply chain and regulatory teams, maintain QMS records, train staff, and support audits. Base pay ranges from $98,140 to $134,937, with eligibility for commissions depending on plan.