Sr Quality Engineer

Overview

Join Vital Path in Maplewood as a Sr Quality Engineer. Vital Path is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.

Our employees' impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence. As a fast-growing organization, we bring harmony and standardization across Vital Path with a strong vision in mind – We are one Vital Path.

We embrace our diversity, celebrate each others' success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that Vital Path is an employer of choice. If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

The Sr Quality Engineer is primarily responsible for providing technical support to ensure customer requirements are understood and properly implemented. The Sr Quality Engineer will work cross-functionally contributing to development and manufacturing engineering qualification and validation activities. Supports Operations, Sales, and Quality by providing effective non-conformance processing, supplier control and outsourced services integrity, complaint handling, and related CAPA activities. Providing effective technical support and supervision to the QC/QA inspection related functions to directly ensure a consistently high level of processing performance.

• This position requires the employee to be onsite at our Maplewood, MN location.
• This position will require occasional travel to other Vital Path locations including New Hope and Cokato, MN.
• Vital Path does not offer relocation assistance for this position.

• Support and/or lead Qualification activities required by manufacturing process release.
• Support and/or contribute to process validation activities required for manufacturing process transfer.
• Champion and/or work jointly with manufacturing Engineers in effective processing of non-conformance events.
• Champion customer complaint and related CAPA processing performance.
• Support purchasing and receiving inspection activities to ensure acceptable raw material accuracy and timeliness.
• Support development activities for the transition of manufacturing processes and related controlled documentation (TVR Packages) from prototype control, to pre-production control to commercial production control.
• Promote and encourage strong QMS (Quality Management System), GMP (Good Manufacturing Practices), GDP (Good Documentation Practices) policies and principles throughout the organization.
• Champion and contribute to the QMS internal audit program effectiveness.
• Be available and support any supplier or external audit activities as requested by management.
• Lead and direct an effective QC/QA final inspection team to directly influence high product quality and output performance.
• Support key quality objectives on the production floor, including in-line inspections, lean manufacturing and improving throughput and scrap goals throughout the production and service provision processes.
• Other duties as assigned.

• 5-8 years of experience in ISO/FDA catheter shaft medical manufacturing environment
• Bachelor’s Degree in Engineering, Sciences, Manufacturing, or equivalent related experience in manufacturing or quality control
• Demonstrated skills related to root-cause analysis, SPS, equipment and process qualification, metrology, automation, and auditing are preferred
• Strong communication abilities, confident disposition,…