Supplier Quality Engineer Consultant I

Title: Supplier Quality Engineer Consultant I 
Location: Wallingford, CT
Duration: 12 Months

Experience: More than 5 years professional experience. 
Education: Bachelor's Degree or equivalent unless otherwise specified. 
Prepare monthly QA status reports. 
Participate in customer and regulatory agency audits. 
 • Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device development & testing, including CFRs, ISO, MDD, and other international/regulatory standards. 
 • Provide QE support for Engineering changes by reviewing Change Requests for compliance, completeness and accuracy 
 • Investigate incoming inspection issues 
 • Support the sustaining activities 
 • Provide product data analysis for CAPA investigation 
 • Investigate and resolve CAPA issues as needed 
 • Performs other duties as needed to ensure compliance with relevant FDA QSRs and ISO regulations. 
 • Excellent technical writing, communication, and organization skills and working within FDA or similarly regulated environment, required. 
 • Plans and manages assignments of significant technical scope 
 • Perform technical and non-technical product failure evaluations documenting and effectively communicating root cause findings. 
 • Skilled at performing reviews, system/product failure analysis, First Article Inspections (FAI), and Incoming Inspections, as required. 
 • Skilled in creating, interpreting and modifying component/schematic drawings. 
 • Willingness to work as part of a team and strong verbal and written communication skills are essential. 
 • Able to work independently and complete multiple assignments on time. 
 • Skilled with applying Quality Tools. 
 • Skilled in Internal Auditing duties. 
 • Capable of making technical calculations involving the use of engineering and mathematical formulas such as finding standard deviations. 
 • Skilled at trouble shooting and problem solving. 
 • Skilled at interacting directly with suppliers, operation/manufacturing services and engineering support services. 
 • Understanding Software Validation is preferred. 
 • Skilled with Word or other word processing software, and SAP (or related) navigation, required. Experiences with multiple statistical/QS software packages are a plus. 
 • Write routine procedures and reports and make necessary corrections. 
 • Write and update Quality Inspection Plans. 

Thank you,
Sachin P.,

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