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.