Sr Mgr, Quality Job at Edwards Lifesciences
Key Responsibilities to Include:
Manage and/or oversee the work of assigned team within a site laboratory including responsibilities on on-going projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, department budget, the development and validation of laboratory test methods in support of production and/or new product/process development. Overall leadership in ensuring Lab processes/personnel complies with pertinent Laboratory Environmental and Safety regulations.
Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope, and objectives. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards, and guidelines
Develop a robust talent development plan in alignment with functional growth strategies of the department including meeting the needs of the organization and customers and to better understand core competencies
Lead in the development, monitoring and publishing of appropriate metrics for the organization
Assess work techniques and provide feedback on policies and procedures
Provide solutions and lead in the validation, qualification, and troubleshooting of laboratory test methods and analytical equipment
Perform structural elucidation (mass spectral interpretation) of data generated by a variety of analytical equipment as part of testing for Extractables and Leachables.
Perform test method development and validation of test methods using various chromatographic-mass spectroscopic techniques (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Provide strategy on root cause analysis for sample failures and Out-of-Specifications (OOS), non-conformances, and CAPA and guide other chemists perform investigations
Perform testing as needed
Knowledge and Skills:
Technical knowledge of theory and application in structural elucidation (mass spectral interpretation) using a variety of chromatographic techniques utilizing mass spectrometer(s) (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Proficient experience with test method development and validation using analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)) following ICH, FDA, and USP guidelines.
Proficient experience with troubleshooting and qualifying analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Ability to manage confidential information with discretion
Other Requirements:
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Work is performed independently and reviewed from a relatively long-term perspective for desired results
Act as a resource for colleagues with less experience and may lead the work of project teams
Typical Education / Experience
Education/Experience:
Bachelor's Degree in Chemistry with 10 years of related experience or Master's Degree in Chemistry with 8 years of related experience or PhD in Chemistry with 2 years of related experience required
Necessary Experience
Technical knowledge of theory and application in structural elucidation (mass spectral interpretation) using a variety of chromatographic techniques utilizing mass spectrometer(s) (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Proficient experience with test method development and validation using analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)) following ICH, FDA, and USP guidelines.
Proficient experience with troubleshooting and qualifying analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Experience in a regulated environment (FDA, DEKRA, etc.)
Excellent problem-solving, organizational, analytical and critical thinking skills
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
blog.nvalabs.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blog.nvalabs.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
Manage and/or oversee the work of assigned team within a site laboratory including responsibilities on on-going projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, department budget, the development and validation of laboratory test methods in support of production and/or new product/process development. Overall leadership in ensuring Lab processes/personnel complies with pertinent Laboratory Environmental and Safety regulations.
Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope, and objectives. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards, and guidelines
Develop a robust talent development plan in alignment with functional growth strategies of the department including meeting the needs of the organization and customers and to better understand core competencies
Lead in the development, monitoring and publishing of appropriate metrics for the organization
Assess work techniques and provide feedback on policies and procedures
Provide solutions and lead in the validation, qualification, and troubleshooting of laboratory test methods and analytical equipment
Perform structural elucidation (mass spectral interpretation) of data generated by a variety of analytical equipment as part of testing for Extractables and Leachables.
Perform test method development and validation of test methods using various chromatographic-mass spectroscopic techniques (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Provide strategy on root cause analysis for sample failures and Out-of-Specifications (OOS), non-conformances, and CAPA and guide other chemists perform investigations
Perform testing as needed
Knowledge and Skills:
Technical knowledge of theory and application in structural elucidation (mass spectral interpretation) using a variety of chromatographic techniques utilizing mass spectrometer(s) (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Proficient experience with test method development and validation using analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)) following ICH, FDA, and USP guidelines.
Proficient experience with troubleshooting and qualifying analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Ability to manage confidential information with discretion
Other Requirements:
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Work is performed independently and reviewed from a relatively long-term perspective for desired results
Act as a resource for colleagues with less experience and may lead the work of project teams
Typical Education / Experience
Education/Experience:
Bachelor's Degree in Chemistry with 10 years of related experience or Master's Degree in Chemistry with 8 years of related experience or PhD in Chemistry with 2 years of related experience required
Necessary Experience
Technical knowledge of theory and application in structural elucidation (mass spectral interpretation) using a variety of chromatographic techniques utilizing mass spectrometer(s) (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Proficient experience with test method development and validation using analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)) following ICH, FDA, and USP guidelines.
Proficient experience with troubleshooting and qualifying analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
Experience in a regulated environment (FDA, DEKRA, etc.)
Excellent problem-solving, organizational, analytical and critical thinking skills
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
blog.nvalabs.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blog.nvalabs.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.