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Senior Quality Engineer

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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 between $80,000-$100,000 annually, depending on experience, skills, qualifications.
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.

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What You Should Know About Senior Quality Engineer, Nextern

At Nextern, we’re excited to announce an opening for a Senior Quality Engineer who will play a vital role in maintaining our exceptional quality standards while working closely with our key customers in the Integrated Systems and Therapy Delivery businesses. In this dynamic position, you will be the advocate for our customers’ quality expectations, making sure our daily performance in engineering, manufacturing, and supply chain exceeds those expectations. This isn’t just a job; it’s a chance to lead and drive quality initiatives, oversee critical processes such as CAPA and SCAR, and mentor junior staff as they rise to new challenges. You will collaborate with skilled teams in our supply chain resources located in China and Vietnam and ensure that complex electronic devices meet the highest standards. Your technical expertise will shine as you perform root cause analysis and implement corrective actions that make a real difference. A master's degree in engineering management or a related field, complemented by two years of relevant experience, is needed to thrive in this role. Additionally, your background in risk management, process validation, and the analysis of device data using tools like Minitab will be invaluable. And let’s not forget about our perks! Competitive salary and comprehensive benefits like paid time off and Taco Thursdays await you here. Join us at Nextern, where your talent and efforts contribute to our success and make a difference in the healthcare industry.

Frequently Asked Questions (FAQs) for Senior Quality Engineer Role at Nextern

What are the responsibilities of a Senior Quality Engineer at Nextern?

The Senior Quality Engineer at Nextern is responsible for managing the quality relationship with key customers, overseeing processes like CAPA and SCAR, and ensuring compliance with internal standards across engineering, manufacturing, and supply chain. You will lead root cause analyses and mentor staff to address quality issues, alongside collaborating with suppliers to ensure they meet our quality expectations.