Quality Engineer - CAPA

Siemens Healthineers; Knoxville (TN); On-site; USD 98,140 - 134,937; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Paid parking/public transportation

Job summary

Siemens Healthineers is seeking a dedicated Quality Engineer to manage and enhance CAPA programs, ensuring compliance with ISO 13485, FDA, and other regulations. The role focuses on investigation, root cause analysis, and effective corrective/preventive actions to improve product quality and operational efficiency.

The ideal candidate has 2+ years in quality engineering, experience with CAPA in regulated industries, and strong analytical and communication skills to train staff and drive

Qualifications

• Bachelor’s degree in engineering, Quality Management, or related field; advanced degree or certifications preferred.
• Minimum of 2+ years of experience in quality engineering or a related role.
• Proven CAPA management experience in regulated industries (medical devices, aerospace, pharmaceuticals, or manufacturing).
• Familiarity with ISO 13485 and 21 CFR Part 820.

Responsibilities

• Lead end‑to‑end CAPA process: identification, documentation, investigation, root cause analysis, corrective actions, and verification.
• Facilitate CAPA board meetings; document minutes and track action items.
• Design, implement, and maintain CAPA processes aligned with ISO 13485, MDSAP, FDA, and company policies.
• Use quality tools (5 Whys, Fishbone, FMEA) to identify root causes and implement effective solutions.
• Ensure CAPA records meet regulatory and audit requirements within the QMS.
• Collaborate with engineering, manufacturing, supply chain, and regulatory teams to resolve quality issues.
• Train staff on CAPA processes and promote a culture of quality and continuous improvement.
• Administer CAPA software, manage user accounts, and monitor metrics for leadership reviews.
• Serve as SME during audits and support backroom/frontroom activities.
• Conduct internal audits for the Molecular Imaging audit program.

Skills

Analytical skills

Problem solving

Cross‑functional collaboration

Communication skills

Detail oriented

Education

Bachelor's degree in engineering or quality management

ASQ CQE or Six Sigma certification preferred

Tools

CATSweb

MasterControl

TrackWise

Job description

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).

Responsibilities

• 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.

Compensation & Benefits

Base Pay Range: $98,140 – $134,937. Factors that may impact starting pay include geography, skills, experience, and other qualifications.

Benefits (subject to eligibility): 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 affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to 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.