Redbock - an NES Fircroft company · 6 hours ago
Sr. Quality Engineer
Minneapolis, MN
Contract
Hybrid
Senior Level
$45/hr - $60/hr
5+ years expRedbock, an NES Fircroft company, is seeking a Sr. Quality Engineer for a 6-month contract position in Minneapolis, MN. The role involves leading global quality improvement projects and ensuring compliance with regulatory standards while achieving efficiency targets.
BiotechnologyConsultingMedical DevicePharmaceutical
No H1B
Responsibilities
Be the quality lead representative on global quality improvement, cost-down, and efficiency projects
Engage in, review, and approve qualification deliverables, protocols, and processes
Ensure products and quality processes maintain regulatory compliance while achieving cost down and efficiency targets
Ensure internal quality processes, procedures and systems are compliant to all governing standards
Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation
Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans and reports
Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements
Support CAPA investigations, improvements, and effectiveness verification testing
Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Qualification
Required
General quality experience in med device preferred
Design Assurance/Design Quality, including risk management, design V&V, and design transfer activities
Self-driven, independent ability to engage with cross functional teams and manage project workload
Lean/six sigma project improvement experience
Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation
Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
Experience with Lean/Six Sigma efficiency projects
Target Years of Experience: 5-7 yrs depending on education and experience
Preferred
Experience with electronics manufacturing including wafer fabrication and electronics assembly
Six Sigma or DRM certification
Strong statistical analysis techniques
Company
Redbock - an NES Fircroft company
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2018-06-20Acquired
Company data provided by crunchbase