Shsjb
Head of Lab Solutions Manufacturing Quality
Shsjb, San Jose, California, United States, 95116
Join Us In Pioneering Breakthroughs In Healthcare
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. Develop and execute centralized Quality Management strategy across Laboratory Diagnostics (LD) Business enterprise. Collaborate across all sites and functions to drive process & operational excellence with focus on lean manufacturing, agile design control processes, and digital Quality System tool implementation. Lead high level goals and critical Quality-led initiatives across the enterprise. Drive quality Key Performance Indicators (KPIs) metrics across sites and report results to management with focus on digital dashboard implementation. Propose preventive measures across sites, promote and implement improvement programs. Position Reports To: Head of QT-LS Responsibilities Demonstrate and apply advanced Quality System expertise to address complex issues independently. Direct a team of quality professionals focusing on Operational Quality, Supplier, Audit and Project Management. Execute LD wide internal quality audits with focus on value-add auditing. Ensure overall site external audit readiness. Harmonize quality process and practices across the Lab Solutions manufacturing and logistics sites. Lead & deliver quality communications. Leadership with a high focus on developing the culture and engagement of the GMQ team through feedback, listening, coaching, and talent development. Required Knowledge/Skills, Education, and Experience BS/BA in engineering or science discipline. Advanced degree preferred. Typically, 10-15 years of successful experience in Quality Management field. Manufacturing experience preferred. Experience interfacing directly with regulatory authorities (e.g. FDA) in inspections, submissions, and/or Field Action negotiations. Advanced knowledge of FDA regulations, EU IVD Directive, new EU IVD Regulations, ISO 13485, and MDSAP. Strong leadership skills including prior history of leading a team of over 15 members. Must have strong written and verbal communication skills, including strong experience with presentations to senior management. Travel may be up to 20% for this position. Preferred Knowledge/Skills, Education, and Experience Strong leadership skills including influence management skills. Strong ability to collaborate across other functional areas. Strong team player and business partner. Experience with setting multi-site QMS and implementing process improvements. Expertise is deploying digital tools across multiple owners and culture. Familiarity with EHS regulations such as REACH, RoHS, ISO 45001 would be helpful. We are a team of more than 73,000 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. 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. The annual base pay for this position is: Min $240,000 - Max $360,000. 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. The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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. 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 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. Applicants and employees are protected under Federal law from discrimination. Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. California residents have the right to receive additional notices about their personal information. To learn more, click here. 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. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
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. Develop and execute centralized Quality Management strategy across Laboratory Diagnostics (LD) Business enterprise. Collaborate across all sites and functions to drive process & operational excellence with focus on lean manufacturing, agile design control processes, and digital Quality System tool implementation. Lead high level goals and critical Quality-led initiatives across the enterprise. Drive quality Key Performance Indicators (KPIs) metrics across sites and report results to management with focus on digital dashboard implementation. Propose preventive measures across sites, promote and implement improvement programs. Position Reports To: Head of QT-LS Responsibilities Demonstrate and apply advanced Quality System expertise to address complex issues independently. Direct a team of quality professionals focusing on Operational Quality, Supplier, Audit and Project Management. Execute LD wide internal quality audits with focus on value-add auditing. Ensure overall site external audit readiness. Harmonize quality process and practices across the Lab Solutions manufacturing and logistics sites. Lead & deliver quality communications. Leadership with a high focus on developing the culture and engagement of the GMQ team through feedback, listening, coaching, and talent development. Required Knowledge/Skills, Education, and Experience BS/BA in engineering or science discipline. Advanced degree preferred. Typically, 10-15 years of successful experience in Quality Management field. Manufacturing experience preferred. Experience interfacing directly with regulatory authorities (e.g. FDA) in inspections, submissions, and/or Field Action negotiations. Advanced knowledge of FDA regulations, EU IVD Directive, new EU IVD Regulations, ISO 13485, and MDSAP. Strong leadership skills including prior history of leading a team of over 15 members. Must have strong written and verbal communication skills, including strong experience with presentations to senior management. Travel may be up to 20% for this position. Preferred Knowledge/Skills, Education, and Experience Strong leadership skills including influence management skills. Strong ability to collaborate across other functional areas. Strong team player and business partner. Experience with setting multi-site QMS and implementing process improvements. Expertise is deploying digital tools across multiple owners and culture. Familiarity with EHS regulations such as REACH, RoHS, ISO 45001 would be helpful. We are a team of more than 73,000 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. 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. The annual base pay for this position is: Min $240,000 - Max $360,000. 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. The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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. 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 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. Applicants and employees are protected under Federal law from discrimination. Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. California residents have the right to receive additional notices about their personal information. To learn more, click here. 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. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.