Senior Supplier Quality Engineer, External Manufacturing / CMOs (Remote) Job at Edwards Lifesciences
This Senior Supplier Quality Engineer applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities :
Partner and interact with CMOs (Contract Manufacturing Organizations); manage any non-conformances with these manufacturers; and make sure the CMO’s quality standards and quality systems are in alignment with Edwards Lifesciences’ quality standards/systems.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
Initiate and participate in the completion of a Product Risk Assessment for relevant complaints. Attend and support Risk Management Council and Quality Review Board for Field Corrective Action decisions.
Drive and manage sub-tier supplier qualification activities to ensure adherence to EW quality standards.
Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Develop technical content of risk management files.
Oversee Quality support tasks and mentor, train, coach, and provide instruction to less experienced engineers.
Identification of new CMOs including optimization of Edward’s supplier base. This includes improving, restricting, or exiting suppliers.
Drive change management process for CMOs to include design control, validation, and qualification for sustaining engineering activities.
Other incidental duties
Required Qualifications :
Bachelor's Degree in Engineering or Scientific field with at least (4) years of quality/manufacturing experience; OR a Master's Degree in Engineering or Scientific field with at least (3) years of quality/manufacturing experience
Medical Device, Pharma, Automotive, or Aerospace industrial experience.
Preferred Qualifications :
Degree in Electrical or Mechanical Engineering
Experience partnering with and managing Suppliers, specifically CMO and/or OEM and their activities
Manufacturing process controls knowledge and experience (process flow, FMEA, Control plans, Mistake Proofing, Statistical Process Control,).
Project Management Certification or experience.
Knowledge of DMAIC Six Sigma concepts with ability to apply to work product
Experience managing non-conformances, performing audits, and coordinating notification of changes with manufacturers
In-depth knowledge of Quality Management Systems and Processes
Demonstrated experience evaluating investigations; assessing and monitoring data from these investigations; and leading Quality Data Reviews with Suppliers
Good project management skills
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $101,000 to $142,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).
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 :
apexdining.ca 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, apexdining.ca 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.
Key Responsibilities :
Partner and interact with CMOs (Contract Manufacturing Organizations); manage any non-conformances with these manufacturers; and make sure the CMO’s quality standards and quality systems are in alignment with Edwards Lifesciences’ quality standards/systems.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
Initiate and participate in the completion of a Product Risk Assessment for relevant complaints. Attend and support Risk Management Council and Quality Review Board for Field Corrective Action decisions.
Drive and manage sub-tier supplier qualification activities to ensure adherence to EW quality standards.
Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Develop technical content of risk management files.
Oversee Quality support tasks and mentor, train, coach, and provide instruction to less experienced engineers.
Identification of new CMOs including optimization of Edward’s supplier base. This includes improving, restricting, or exiting suppliers.
Drive change management process for CMOs to include design control, validation, and qualification for sustaining engineering activities.
Other incidental duties
Required Qualifications :
Bachelor's Degree in Engineering or Scientific field with at least (4) years of quality/manufacturing experience; OR a Master's Degree in Engineering or Scientific field with at least (3) years of quality/manufacturing experience
Medical Device, Pharma, Automotive, or Aerospace industrial experience.
Preferred Qualifications :
Degree in Electrical or Mechanical Engineering
Experience partnering with and managing Suppliers, specifically CMO and/or OEM and their activities
Manufacturing process controls knowledge and experience (process flow, FMEA, Control plans, Mistake Proofing, Statistical Process Control,).
Project Management Certification or experience.
Knowledge of DMAIC Six Sigma concepts with ability to apply to work product
Experience managing non-conformances, performing audits, and coordinating notification of changes with manufacturers
In-depth knowledge of Quality Management Systems and Processes
Demonstrated experience evaluating investigations; assessing and monitoring data from these investigations; and leading Quality Data Reviews with Suppliers
Good project management skills
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $101,000 to $142,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).
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 :
apexdining.ca 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, apexdining.ca 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.