(MULTIPLE OPENINGS)
Responsible for tactical management of the quality relationship between Nextern and key customers in the Integrated Systems and Therapy Delivery businesses. The Senior Quality Engineer will advocate for the customers’ quality expectations and requirements of our day to day performance in engineering, manufacturing, and supply chain.
Specific duties include:
· Oversee processes such as CAPA and SCAR, process qualification and validation, equipment selection and qualification, process control and yield, trend monitoring, return material authorization, failure analysis of returned products, serving and refurbishment of fielded products, and non-conforming material processing.
· Demonstrate technical leadership and expertise to contain issues; oversee determination of root cause of issues, mentor staff to take corrective actions internal to Nextern and collaboratively with customers, and direct with the supplier management organization on any necessary corrective/preventive actions to be implemented by the supplier.
· Use expertise to oversee various systems, applications, and tools including database analysis, material and inventory movements; enterprise QMS, common business applications, electronic record management system, and collaboration and accountability applications. Provide leadership to junior engineering staff.
· Collaborate with strategic supply chain resources located in China and Vietnam to qualify suppliers and parts for complex electronic devices.
Requires a master’s degree in engineering management or a related field and two years of experience.
Experience must include:
· Risk Management process execution, including development and update of Process FMEAs.
· Process Validation and ongoing process control of specialty medical device processes including hydrophilic coating, injection molded components, adhesive bonding and curing, extrusion, wire braiding and coiling, laser bonding, Nitinol heat setting, and other state of the art technologies.
· Test Method identification, implementation and validation of automated inspection technologies.
· Failure Analysis of Returned Goods and establishing rework and refurbishment processes, or identifying root causes of field failures.
· Analysis of process and device data using statistical techniques in Minitab and Microsoft Excel.
· Experience with Oracle Agile and Epicor software systems.
- The expected salary for this position is $90,130-$100,000.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
