Sr Quality Engineer

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

• 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, 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