Senior Quality Engineer
Our client is a leader in innovative technologies that address the unmet needs in cardiovascular diseases. They have an opportunity for a Senior Quality Engineer.
In this role you will provide quality and reliability products for new product development, manufacturing and supplier operations - risk management, design validation, supplier and component qualification, and process qualification/validation processes. As well, assist in addressing field issues, CAPAs, complaints, and clinical adverse events.
- Plan, perform, coordinate, and/or oversee design validation testing and reporting for product hardware, software and firmware
- Review Test Plans and associated Test Reports for production and qualification screens and tests
- Provide quality and reliability support of manufacturing operations
- Provide leadership for process failure mode effects analysis
- Provide input or generation and review of process evaluations, characterizations, qualifications, and validations
- Plan, perform, coordinate, and oversee supplier and component selection and qualification
- Perform, review and approve equipment selection and qualification activities as required
- Provide statistical analysis and sample size inputs to production and development qualification/validation testing and data
- Provide ownership or oversight to specific corrective and preventive action issues, as assigned
- Perform and lead internal audits for compliance to regulations and SOPs
- Oversee internal calibration activities
- Perform other duties as assigned
- BS Degree - Science or Engineering or technical equivalent plus 5 yrs working experience in a medical device company
- Knowledge of FDA QSR and ISO 13485 regulatory requirements (guidelines and standards that pertaain to medical devices)
- Knowledge of additional international regulations, radio equipment regulations, and risk management and cybersecurity standards - A Plus!
- Class III implantable medical device experience - Active implantables experience - A Plus!
- Collaborative Team Player with internal and external customers in all aspects of the product life cycle
- Ability to apply statistics to solve problems and determine sampling plans
- Previous experience with risk and hazard analysis
- Previous education or experience in electrical engineering or electronics with software experience – Preferred!
- Ability to travel for business as needed
Keywords: quality engineer, engineering, medical device, validation testing, reliability
"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".