Quality Engineer - CAPA

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

Quality Engineer - CAPA (Finance)

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Siemens Healthineers is seeking a dedicated and detail-oriented Quality Engineer to manage and enhance our Corrective and Preventive Action (CAPA) program and processes. The Quality Engineer will be responsible for overseeing the development, implementation, and maintenance of CAPA processes to ensure compliance with regulatory standards and drive continuous improvement in product quality and operational efficiency. This role requires strong analytical skills, cross-functional collaboration, and expertise in quality management systems (QMS).

You are responsible for:

• Leading the end-to-end CAPA process, including identification, documentation, investigation, root cause analysis, corrective/preventive action planning, implementation, and effectiveness verification.
• Facilitating cross-functional CAPA board meetings, documenting minutes, and following up on action items.
• Designing, implementing, and maintaining CAPA processes in alignment with ISO 13485, MDSAP, FDA regulations, and company policies.
• Utilizing quality tools (e.g., 5 Whys, Fishbone Diagrams, FMEA) to identify root causes of non-conformances and implement effective solutions.
• Ensuring CAPA documentation meets regulatory and audit requirements while maintaining accurate records in the QMS.
• Collaborating with engineering, manufacturing, supply chain, and regulatory teams to resolve quality issues and implement CAPA solutions.
• Training staff on CAPA processes and promoting a culture of quality and continuous improvement.
• Administering the CAPA software tool, including creating and managing user accounts.
• Monitoring CAPA metrics, generating reports, and presenting findings to leadership to drive data-driven decisions.
• Serving as Subject Matter Expert during internal and external audits, supporting backroom and frontroom activities.
• Conducting internal audits for the Molecular Imaging audit program.

Minimum Qualifications:

• Bachelor's degree in engineering, Quality Management, or a related field. Advanced degree or certifications (e.g., ASQ CQE, Six Sigma) preferred.
• Minimum of 2+ years of experience in quality engineering or a related role.
• Proven experience managing CAPA programs in a regulated industry (e.g., medical devices, aerospace, pharmaceuticals, or manufacturing).
• Familiarity with quality management systems (e.g., ISO 13485, 21 CFR Part 820).
• Strong knowledge of CAPA processes, root cause analysis, and quality tools.
• Excellent problem-solving and analytical skills.
• Proficiency in QMS software (e.g., CATSweb, MasterControl, TrackWise, or similar).
• Strong communication and interpersonal skills for cross-functional collaboration.
• Detail-oriented with a focus on compliance and documentation.

Preferred Qualifications:

• Experience with regulatory audits and inspections.
• Knowledge of lean manufacturing or Six Sigma methodologies.
• Ability to manage multiple CAPA projects simultaneously.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$98,140 - $134,937

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

Benefits:

• medical insurance, dental insurance, vision insurance, 401(k) retirement plan.
• life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Aff... All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law:

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information. To learn more, click here.

Export Control:

"A successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

Salary Minimum: 98140Salary Maximum: 134937