Sr Quality Engineer VitalPath - 2.3 Saint Paul, MN Job Details Full-time $84,651 - $110,000 a year 7 hours ago Benefits Health savings account AD&D insurance Paid holidays Disability insurance Health insurance Dental insurance Paid time off Parental leave Vision insurance 401(k) matching Opportunities for advancement Life insurance Qualifications FDA regulations Customer complaint resolution Full Job Description Join VitalPath in Maplewood as a Sr Quality Engineer! About VitalPath VitalPath 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 VitalPath with a strong vision in mind - We are one VitalPath. 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 VitalPath 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! About the Position 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 so to directly ensure a constantly high-level of processing performance. Work Location/Schedule This position requires the employee to be onsite at our Maplewood MN location. VitalPath does not offer relocation assistance for this position. Responsibilities 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 nonconformance 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 preproduction control to commercial production control. Promote and encourage strong QMS (Quality Management System), GMP (Good Manufacturing Practices), GDP (Good Documentations 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 inline inspections, lean manufacturing and improving throughput and scrap goals throughout the production and service provision processes. Other duties as assigned. Required Qualifications 58 years of experience in ISO/FDA catheter shaft medical manufacturing environment Bachelor's Degreen in Engineering, Sciences, Manufacturing, or equivalent related experience in manufacturing or quality control Demonstrated skills related to rootcause analysis, SPS, equipment and process qualification, metrology, automation, and auditing are preferred Strong communication abilities, confident disposition, team player, and a robust tool box of relevant software applications (business and quality) Able to sit/stand at a desk for extended periods of time Preferred Qualifications Previous experience with Class II or Class III medical device contract manufacturing and extrusion experience is preferred Compensation Package The salary range for this position is $84,651 $110,000 . The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity. This position is eligible to earn an annual performance bonus based on meeting VitalPath's bonus performance plan. Benefits Comprehensive, Low Cost Health and Dental Insurance Plans Available Vision Insurance Health Savings Account with company contribution Short and Long Term Disability Supplemental insurances (short term disability, AD&D, life insurance, and more) Parental Leave Paid Time Off Minnesota Earned Sick & Safe Time Paid Holidays 401K with company match Opportunities for career growth and advancement VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify. About VitalPath We are 100% focused on complex catheters and precision laser components and are an approved supplier for many Tier 1 OEMs. With our engineers' deep technical knowledge, well-developed proprietary processes, dedication to following through our commitments, and extensive in-house capabilities, we're the best-kept secret in the medical device industry. Join our VitalPath team! The passion, hard work, and dedication of our vital team members is core to our success. Every function within our organization plays a crucial role in achieving our important mission of improving the quality of life for patients around the world.