Sr Quality Engineer

Join VitalPath in Maplewood as a Sr Quality Engineer!

About VitalPath
VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!

About the Position
The Sr Quality Engineer is primarily responsible for providing technical support to ensure customer requirements are understood and properly implemented.  He/She 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.

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 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 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 in-line inspections, lean manufacturing and improving throughput and scrap goals throughout the production and service provision processes.
• Other duties as assigned.

• Bachelor’s Degreen in Engineering, Sciences, Manufacturing, or equivalent related experience in manufacturing or quality control.
• 5-8 years of experience in ISO/FDA catheter shaft medical manufacturing environment
• Demonstrated skills related to root-cause 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)
• Previous experience with Class II or Class III medical device contract manufacturing and extrusion experience is preferred.
• Able to sit/stand at a desk for extended periods of time.

• 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)
• Paid Time Off
• Sick Time Off
• Paid Holidays
• 401K with company match
• Competitive compensation
• 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.