Cypress HCM · 22 hours ago
Sr Quality Engineer
New Hope, MN
Full-time
Onsite
Mid, Senior Level
$85K/yr - $110K/yr
5+ years expCypress HCM is a staffing agency partnering with a medical manufacturing client in New Hope, Minnesota. They are seeking a Senior Quality Engineer responsible for providing technical support to ensure customer requirements are met and to contribute to engineering qualification and validation activities.
Human ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Lareina Rodriguez
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
Qualification
Required
5-8 years of experience in ISO/FDA 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
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 complex catheters and extrusion experience
Benefits
8% bonus
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase