Siemens Healthineers
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Quality Systems Engineer
role at
Siemens Healthineers
Overview Varian Medical Systems, a Siemens Healthineers company, is seeking an onsite highly skilled and motivated
Quality Systems Engineer
for our Palo Alto, California location to lead the implementation and continuous improvement of quality systems. This role will primarily focus on CAPA & Non-Conformance Management, Audit & Compliance, Performance Metrics & Reporting, and driving cross-functional collaboration to optimize processes and performance.
What You Will Do
Quality Strategy Implementation & QMS Development: Implement the global quality strategy, ensuring alignment with business goals and regulatory standards. Continuously enhance the Quality Management System (QMS) and maintain quality documentation, regulations, methods, and IT tools.
Cross-functional Collaboration: Partner with R&D, Procurement, Manufacturing, and other business units to integrate and optimize quality management practices across the organization.
Audit & Compliance: Participate in internal audits, ensuring compliance with ISO and regulatory standards. Address non-conformities (NC) and implement corrective actions effectively.
Process Improvement & Digital Solutions: Drive process optimization using Six Sigma, Lean, and quality tools (8D, RCA, FMEA). Lead the development of digital solutions to enhance quality performance and optimize processes.
Training & Development: Participate in the development and deployment training programs to ensure employees are equipped to maintain quality standards and support continuous improvement.
CAPA & Non-Conformance Management: Support the identification, documentation, and resolution of CAPA processes. Ensure non-conformities are promptly addressed and resolved with cross-functional collaboration.
Performance Metrics & Reporting: Establish and monitor quality metrics and benchmarks. Provide regular reporting and insights to leadership to guide decision-making and continuous improvement.
Safety Management: Develop and integrate safety standards into the quality system to maintain a safe work environment.
Improvement Projects: Propose, lead, and take responsibility for defined improvement projects, ensuring successful execution and driving continuous improvement across quality processes.
What You Will Have
In-depth knowledge of quality management standards (e.g., ISO 13485:2016, FDA CFR 820).
Proficient in Microsoft Office and ERP systems (e.g., Workday, SAP, MES).
Strong problem-solving and data analysis skills, with experience using statistical tools.
Expertise in implementing Six Sigma, Lean, and quality tools (e.g., 8D, RCA, FMEA) for continuous improvement.
Ability to lead and coach cross-functional teams, fostering a quality-driven culture.
Familiarity with safety management systems and integrating safety protocols into quality practices.
Experience in CAPA processes and non-conformance management.
Skilled in designing and delivering training programs to support quality initiatives.
Strong ability to establish, monitor, and analyze quality metrics and performance benchmarks.
Proven track record of leading improvement projects and driving organizational change.
Education & Experience
Bachelor’s degree in Engineering, Quality Management, or a related field, or equivalent experience.
5+ years of experience in quality management or related roles, or 3+ years with a Master’s degree.
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 any other categories protected by federal, state or local law.
EEO is the Law: Applicants and employees are protected under Federal law from discrimination.
Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. We will provide reasonable accommodations for persons with disabilities participating in the hiring process.
If you require a reasonable accommodation in completing a job application, interviewing, or other pre-employment activities, please contact the HR team as specified in the job posting.
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Quality Systems Engineer
role at
Siemens Healthineers
Overview Varian Medical Systems, a Siemens Healthineers company, is seeking an onsite highly skilled and motivated
Quality Systems Engineer
for our Palo Alto, California location to lead the implementation and continuous improvement of quality systems. This role will primarily focus on CAPA & Non-Conformance Management, Audit & Compliance, Performance Metrics & Reporting, and driving cross-functional collaboration to optimize processes and performance.
What You Will Do
Quality Strategy Implementation & QMS Development: Implement the global quality strategy, ensuring alignment with business goals and regulatory standards. Continuously enhance the Quality Management System (QMS) and maintain quality documentation, regulations, methods, and IT tools.
Cross-functional Collaboration: Partner with R&D, Procurement, Manufacturing, and other business units to integrate and optimize quality management practices across the organization.
Audit & Compliance: Participate in internal audits, ensuring compliance with ISO and regulatory standards. Address non-conformities (NC) and implement corrective actions effectively.
Process Improvement & Digital Solutions: Drive process optimization using Six Sigma, Lean, and quality tools (8D, RCA, FMEA). Lead the development of digital solutions to enhance quality performance and optimize processes.
Training & Development: Participate in the development and deployment training programs to ensure employees are equipped to maintain quality standards and support continuous improvement.
CAPA & Non-Conformance Management: Support the identification, documentation, and resolution of CAPA processes. Ensure non-conformities are promptly addressed and resolved with cross-functional collaboration.
Performance Metrics & Reporting: Establish and monitor quality metrics and benchmarks. Provide regular reporting and insights to leadership to guide decision-making and continuous improvement.
Safety Management: Develop and integrate safety standards into the quality system to maintain a safe work environment.
Improvement Projects: Propose, lead, and take responsibility for defined improvement projects, ensuring successful execution and driving continuous improvement across quality processes.
What You Will Have
In-depth knowledge of quality management standards (e.g., ISO 13485:2016, FDA CFR 820).
Proficient in Microsoft Office and ERP systems (e.g., Workday, SAP, MES).
Strong problem-solving and data analysis skills, with experience using statistical tools.
Expertise in implementing Six Sigma, Lean, and quality tools (e.g., 8D, RCA, FMEA) for continuous improvement.
Ability to lead and coach cross-functional teams, fostering a quality-driven culture.
Familiarity with safety management systems and integrating safety protocols into quality practices.
Experience in CAPA processes and non-conformance management.
Skilled in designing and delivering training programs to support quality initiatives.
Strong ability to establish, monitor, and analyze quality metrics and performance benchmarks.
Proven track record of leading improvement projects and driving organizational change.
Education & Experience
Bachelor’s degree in Engineering, Quality Management, or a related field, or equivalent experience.
5+ years of experience in quality management or related roles, or 3+ years with a Master’s degree.
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 any other categories protected by federal, state or local law.
EEO is the Law: Applicants and employees are protected under Federal law from discrimination.
Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. We will provide reasonable accommodations for persons with disabilities participating in the hiring process.
If you require a reasonable accommodation in completing a job application, interviewing, or other pre-employment activities, please contact the HR team as specified in the job posting.
#J-18808-Ljbffr