Manufacturing Quality Engineer II (2 of 2)
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
Abiomed's Patients First! culture drives our skilled workforce and strong relationships with clinicians.
Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed I Am Heart Recovery Patients First! The Manufacturing Quality Engineer II is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on manufacturing activities in the Danvers plant.
KEY RESPONSIBILITIES oProvide quality engineering support in the development and manufacturing of new and existing disposable medical devices.
oEnsure compliance of manufacturing processes and areas to all applicable quality system regulations oMonitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities (CAPA) oValidate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) oWork with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP) oSupport process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products.
Identify key process input variables and key process output variables oSupport Quality Management System (process development, creating and editing new and existing SOPs).
Support internal auditing requirements in manufacturing oLead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs) oLead/support the supplier evaluation process when selecting & qualifying new suppliers; help maintain the ASL, supplier scorecards, and supporting documentation required per SOPs oResolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances Recommended Skills Data Analysis Design Of Experiments Editing Manufacturing Engineering Medical Material Process Development Estimated Salary: $20 to $28 per hour based on qualifications.
Abiomed's Patients First! culture drives our skilled workforce and strong relationships with clinicians.
Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed I Am Heart Recovery Patients First! The Manufacturing Quality Engineer II is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on manufacturing activities in the Danvers plant.
KEY RESPONSIBILITIES oProvide quality engineering support in the development and manufacturing of new and existing disposable medical devices.
oEnsure compliance of manufacturing processes and areas to all applicable quality system regulations oMonitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities (CAPA) oValidate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) oWork with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP) oSupport process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products.
Identify key process input variables and key process output variables oSupport Quality Management System (process development, creating and editing new and existing SOPs).
Support internal auditing requirements in manufacturing oLead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs) oLead/support the supplier evaluation process when selecting & qualifying new suppliers; help maintain the ASL, supplier scorecards, and supporting documentation required per SOPs oResolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances Recommended Skills Data Analysis Design Of Experiments Editing Manufacturing Engineering Medical Material Process Development Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
