Job Description
Qualifications
General understanding and practical application of global medical device standards and regulations, in particular ISO 13485, 21CFR820, CMDR, MDR, ANVIA, TGA
General knowledge of technical and medical device processes, QMS procedures and analytical methodology
As well as experience with root cause analysis tools, and problem-solving methods such as 8D, Kepner Tregoe, and Ishikawa
Required skills to have for the success of this role
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area
Minimum 3 years in the Medical Device Industry and/or Government Regulatory Agency
Capable of assessing compliance requirements using sound judgement and decision-making skills
Excellent oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders
General project management skills
Ability to work with ambiguity and adapt plan when needed
Ability to work collaboratively to achieve objectives
Good problem-solving skills
Ability to work with minimum supervision
Innovative with the ability to make sound suggestions for improvement
Benefits
The pay range for this position in Issaquah, WA is $80,000 - $+5,000 annually; however, base pay offered may vary depending on job-related knowledge, skills, experience, and geographical location
The annual incentive target is 6% of base pay
Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay
Base pay information is based on market location
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision
Responsibilities
CAPA support and guidance to all Manufacturing, Innovation & Technology, Quality and Operations as required to ensure regulatory compliance, business planning and continuously promote Quality First Time
Monitor work performed by participants of the CAPA System to ensure that those quality records are generated and maintained according to procedure
Gather data and create reports measurable data for periodic reviews of the CAPA System
You will prepare all required documentation of CRB (CAPA Review Board) activities
Track CAPA deliverables across all sites
Understand and overcome different cultural and language obstacles to provide solutions that satisfy, corporate, regional, and local objectives
Analyze data to support the development of strategies to effectively manage the action plans that will resolve the issues
Job description
Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a QMS CAPA Specialist .
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
Join our team now at Siemens Healthineers as a QMS CAPA Specialist.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a QMS CAPA Specialist , you will be responsible for:
• CAPA support and guidance to all Manufacturing, Innovation & Technology, Quality and Operations as required to ensure regulatory compliance, business planning and continuously promote Quality First Time.
• Monitor work performed by participants of the CAPA System to ensure that those quality records are generated and maintained according to procedure.
• Gather data and create reports measurable data for periodic reviews of the CAPA System. You will prepare all required documentation of CRB (CAPA Review Board) activities.
• Track CAPA deliverables across all sites
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Siemens-Healthineers Ultrasound business:
• General understanding and practical application of global medical device standards and regulations, in particular ISO 13485, 21CFR820, CMDR, MDR, ANVIA, TGA.
• General knowledge of technical and medical device processes, QMS procedures and analytical methodology. As well as experience with root cause analysis tools, and problem-solving methods such as 8D, Kepner Tregoe, and Ishikawa.
• Understand and overcome different cultural and language obstacles to provide solutions that satisfy, corporate, regional, and local objectives.
• Analyze data to support the development of strategies to effectively manage the action plans that will resolve the issues.
Required skills to have for the success of this role
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum 3 years in the Medical Device Industry and/or Government Regulatory Agency
• Capable of assessing compliance requirements using sound judgement and decision-making skills.
• Excellent oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
• General project management skills.
• Ability to work with ambiguity and adapt plan when needed.
• Ability to work collaboratively to achieve objectives.
• Good problem-solving skills.
• Ability to work with minimum supervision.
• Innovative with the ability to make sound suggestions for improvement.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
The pay range for this position in Issaquah, WA is $80,000 - $+5,000 annually; however, base pay offered may vary depending on job-related knowledge, skills, experience, and geographical location. The annual incentive target is 6% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
#LI-WC1
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Full / Part time: Full-time
Equal Employment Opportunity Statement
Siemens 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, ****** orientation, gender expression, gender identity, transgender, *** 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.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. 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.
General understanding and practical application of global medical device standards and regulations, in particular ISO 13485, 21CFR820, CMDR, MDR, ANVIA, TGA
General knowledge of technical and medical device processes, QMS procedures and analytical methodology
As well as experience with root cause analysis tools, and problem-solving methods such as 8D, Kepner Tregoe, and Ishikawa
Required skills to have for the success of this role
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area
Minimum 3 years in the Medical Device Industry and/or Government Regulatory Agency
Capable of assessing compliance requirements using sound judgement and decision-making skills
Excellent oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders
General project management skills
Ability to work with ambiguity and adapt plan when needed
Ability to work collaboratively to achieve objectives
Good problem-solving skills
Ability to work with minimum supervision
Innovative with the ability to make sound suggestions for improvement
Benefits
The pay range for this position in Issaquah, WA is $80,000 - $+5,000 annually; however, base pay offered may vary depending on job-related knowledge, skills, experience, and geographical location
The annual incentive target is 6% of base pay
Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay
Base pay information is based on market location
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision
Responsibilities
CAPA support and guidance to all Manufacturing, Innovation & Technology, Quality and Operations as required to ensure regulatory compliance, business planning and continuously promote Quality First Time
Monitor work performed by participants of the CAPA System to ensure that those quality records are generated and maintained according to procedure
Gather data and create reports measurable data for periodic reviews of the CAPA System
You will prepare all required documentation of CRB (CAPA Review Board) activities
Track CAPA deliverables across all sites
Understand and overcome different cultural and language obstacles to provide solutions that satisfy, corporate, regional, and local objectives
Analyze data to support the development of strategies to effectively manage the action plans that will resolve the issues
Job description
Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a QMS CAPA Specialist .
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
Join our team now at Siemens Healthineers as a QMS CAPA Specialist.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a QMS CAPA Specialist , you will be responsible for:
• CAPA support and guidance to all Manufacturing, Innovation & Technology, Quality and Operations as required to ensure regulatory compliance, business planning and continuously promote Quality First Time.
• Monitor work performed by participants of the CAPA System to ensure that those quality records are generated and maintained according to procedure.
• Gather data and create reports measurable data for periodic reviews of the CAPA System. You will prepare all required documentation of CRB (CAPA Review Board) activities.
• Track CAPA deliverables across all sites
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Siemens-Healthineers Ultrasound business:
• General understanding and practical application of global medical device standards and regulations, in particular ISO 13485, 21CFR820, CMDR, MDR, ANVIA, TGA.
• General knowledge of technical and medical device processes, QMS procedures and analytical methodology. As well as experience with root cause analysis tools, and problem-solving methods such as 8D, Kepner Tregoe, and Ishikawa.
• Understand and overcome different cultural and language obstacles to provide solutions that satisfy, corporate, regional, and local objectives.
• Analyze data to support the development of strategies to effectively manage the action plans that will resolve the issues.
Required skills to have for the success of this role
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum 3 years in the Medical Device Industry and/or Government Regulatory Agency
• Capable of assessing compliance requirements using sound judgement and decision-making skills.
• Excellent oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
• General project management skills.
• Ability to work with ambiguity and adapt plan when needed.
• Ability to work collaboratively to achieve objectives.
• Good problem-solving skills.
• Ability to work with minimum supervision.
• Innovative with the ability to make sound suggestions for improvement.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
The pay range for this position in Issaquah, WA is $80,000 - $+5,000 annually; however, base pay offered may vary depending on job-related knowledge, skills, experience, and geographical location. The annual incentive target is 6% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
#LI-WC1
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Full / Part time: Full-time
Equal Employment Opportunity Statement
Siemens 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, ****** orientation, gender expression, gender identity, transgender, *** 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.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. 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.
💡 Quick Summary
Seeking a career-building opportunity? The QMS CAPA Specialist position is now open for candidates interested in the Health Jobs sector. This role in Issaquah offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.
