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Quality Engineer

Company: Medinstill Development LLC
Location: Milford
Posted on: May 4, 2022

Job Description:

Job Overview: As Quality Engineer, you will have the responsibility to ensure Quality and Compliance for Medinstill products in accordance with 21 CFR 211 and 820. In addition to developing test methods and protocols to ensure that the appropriate quality tests are being conducted, as Quality Engineer you will support manufacturing process development, process validation and continuous improvement as part of the Quality Team. To be successful in the Quality Engineer role and at MEDinstill you will need: Ability to work independently and be self-directed; Excellent problem solving and analytical skills; Sound organizational and planning skills with a solid attention to detail; Effective communication skills and excellent interpersonal skills; Open and collaborative style; must be comfortable working in an environment where ideas are shared and challenged; Ability to develop and give presentations as well as train associates; Ability to stay focused on the requirements of the customer and process controls; Energy and enthusiasm; enjoy being accountable and willing to hold others accountable; Eager to seek and learn new skills. Primary Responsibilities: Function as manufacturing quality lead. Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO 13485) and company Quality Systems procedures. Maintain batch records and finished goods final release. Perform risk assessment for manufacturing processes including reviewing and updating process FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Responsible for utilizing effective and efficient Quality Engineering techniques such as risk analysis, process development, design of experiments, statistical data analysis, and development of sampling plans during manufacturing. Participate in the process validation activities related to device and drug products. This may include supporting protocol development, testing, and generation of test reports. Participate in the qualification of suppliers of chemicals, components, sub-assembly, and/or test services. Participate in incoming inspection and internal QA audits, as required. Manage suppliers on an ongoing basis via regular contact, periodic audits and other methods to guarantee consistent high quality performance on an ongoing basis. Lead cross-functional Quality Improvement Teams with Suppliers. Support root cause analysis including CAPA investigations, process improvements, and effectiveness verification. Lead and/or support investigations of non-confirming product, material, or processes through the coordination of cross-functional teams while performing the role of Quality Engineer. Education/Experience: Bachelors degree required in engineering, science or technical field with 4 years of experience in Engineering and/or Quality or Advanced degree in engineering, science or technical field with 2 years experience in Engineering and/or Quality. Strong background in statistical analysis and using statistical tools to perform analysis. Strong background in process and product validation including IQ/OQ/PQ, and Test Method Development and Validation. Experience with various quality improvement tools such as Process Mapping, FMEA, DOE, SPC, Gage R&R and Root Cause Analysis. Strong knowledge of Standard Operating Procedures and cGXPs. Strong technical communication skills. Experience with internal and external audits including FDA. Career focus in the medical/Pharma and regulated industries / related professional fields. Six Sigma belt certification a plus

Keywords: Medinstill Development LLC, Milford , Quality Engineer, Engineering , Milford, Connecticut

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