Senior quality assurance engineer - united states, bridgeport

nesco resource is working with a medical device manufacturer in the bridgeport area to find a sr. quality assurance engineer to join their team.
 
summary:
responsible for the planning, design, and implementation of a complete quality control/quality assurance program for manufacturing product group or process.
 
essential duties and key responsibilities:
develop and execute quality engineering tests, validation, and qualification protocols to include procedures, spec sheets and sampling plans utilizing customer's designs and specifications. software validation. conduct process monitoring and measurement using applicable trend analysis tools to measure customer satisfaction, non-conforming material, and customer complaints. perform analysis of test and inspection results using statistical software. inspection methods planning including development and implementation of gages and gauging systems for use by manufacturing and inspection personnel. implement statistical process control techniques including process capability, gage, gr&r studies. interface with customers, suppliers and internal departments in matters concerning quality; including advanced quality planning, product specification development, sterilization validation, shelf life testing, product labeling. develop and implement process control plans, inspection plans and related work instructions. support regulatory affairs as required in matters concerning regulatory compliance and regulatory audits. investigate customer complaints and product failures and recommend corrective actions. performs any and all tasks as required to meet and exceed company commitments. supports on-going production to assure on-time delivery and company profitability. perform training duties for inspectors and manufacturing personnel as required, including gmp training. perform internal and supplier quality system audits. ensures compliance with the organization standards for cost control, waste reduction, quality, safety, on-time delivery.  
skills, abilities and other requirements:

detailed knowledge of principles and practices of quality engineering. kaizen and lean manufacturing techniques. high attention to detail and possess the ability to think ahead. excellent interpersonal and communication skills to work with vendors, customers, and associates. effective organization and analytical skills. ability to multi-task in a fast-paced environment and manage multiple priorities. ability to solve practical problems and deal with a variety of changing situations. knowledge of osha, ansi, and related safety regulations; ability to maintain a safe work environment. ability to apply advanced mathematical concepts. computer proficient in microsoft office, excel, minitab, or other statistical analysis software. proficient knowledge of ansi/asme, y14.5m dimensioning and tolerance.  
reasoning ability:
ability to apply basic reasoning skills to carry out detailed instructions furnished in written, oral, or diagram form. ability to solve problems involving several concrete variables in standardized situations. ability to detect and identify typical defects found in materials. ability to read and use various inspection equipment applications and precision tools and understand and apply basic quality inspection technologies and sound measurement practices. ability to apply level 3 tools to daily work.
 
education and/or experience:
bachelor's degree from a four-year college or university in mechanical or industrial engineering or equivalent and a minimum of 5 years of quality experience to include qc-qa auditing in a manufacturing environment, preferably medical device.
 
additional information:

direct hire with excellent benefits day one 3 weeks of vacation+ 1 week pto (pro-rated in year of hire), medical benefits day one availability, 401k matching 100% up to 4% excellent work life balance
nesco resource and affiliates (lehigh g.i.t inc, and callos resource, llc) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.

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