Senior Quality Engineer – Medical Devices, Impact & Growth

VitalPath; Fort Snelling Unorganized Territory (MN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health and dental insurance

401K with company match

Paid time off

Holidays

Vision insurance

Employee health savings account

Opportunity for career growth

Job summary

VitalPath in Maplewood, MN, is seeking a Sr Quality Engineer to provide technical support ensuring customer requirements are understood and implemented. You will support cross-functional development and manufacturing qualification, handling nonconformances, supplier control, and CAPA activities.

You will supervise QC/QA inspection functions to maintain high processing performance and collaborate with Operations, Sales, and Quality. Onsite work in Maplewood MN is 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.

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.

Skills

Root-cause analysis

Process qualification

Metrology

Automation

Auditing

Communication skills

Team player

Quality software

Education

Bachelor’s Degree in Engineering, Sciences, Manufacturing, or equivalent

Tools

SPS

Metrology equipment

Job description

VitalPath in Maplewood, MN, is seeking a Sr Quality Engineer to provide technical support ensuring customer requirements are understood and implemented. You will support cross-functional development and manufacturing qualification, handling nonconformances, supplier control, and CAPA activities.

You will supervise QC/QA inspection functions to maintain high processing performance and collaborate with Operations, Sales, and Quality. Onsite work in Maplewood MN is required.