Redbock - an NES Fircroft company · 1 hour ago
Quality Engineer II
North Haven, CT
Contract
Onsite
Mid Level
$35/hr - $45/hr
3+ years expRedbock, an NES Fircroft company, is a leading medical device company seeking a Quality Engineer II to work onsite in North Haven, CT. The role involves supporting design quality experience, including Design V&V, Risk Management documentation, and Design Transfer activities, while leading the documentation process for multiple projects simultaneously.
BiotechnologyConsultingMedical DevicePharmaceutical
No H1B
Hiring Manager
Kalyn Burer
Responsibilities
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
W2 Applicants ONLY - No C2C arrangements or sponsorship opportunities
Support design quality experience, including Design V&V, Risk Management documentation (primarily FMEAs), and Design Transfer activities (Change Management and Supplier Qualification)
Lead the documentation process for multiple projects simultaneously through document repositories
Experience with robotics and other complex electromechanical devices will be considered
Risk Management Experience - Failure Mode and Effects Analysis
Supplier Qualification
Design Transfer
Bachelors Degree (preferably in an engineering field)
3- 5 years of product quality
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
Experience with Risk Management (ISO 14971)
Experience with FMEAs
Experience with Design Verification & Validation
Experience with Supplier Qualification and Change Development
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