Quality Engineer

Westfall Technik, LLC seeks Quality Engineer in Ansonia, CT:

Job Duties: Establish, monitor and maintain the Quality Management System processes required for process development, process characterization, equipment qualification, process validation, and other product realization activities as appropriate at the site and apply continuous improvements as appropriate. Collaborate with the internal and external teams to ensure product safety, efficacy, and quality. Well-developed teamwork and collaboration skills and ability to communicate clearly and effectively both verbally and in writing. Strong technical writing and reviewing skills. Sound knowledge and demonstrated compliant application of the Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971. Subject matter expertise and compliant development of production and process controls, risk management plans, product specific quality plans and control strategies along with the execution of these plans through clear and concise quality procedures and quality records established and maintained utilizing good documentation principles. Compliant application of ISO 14971 and the associated risk management tools which includes hazard analysis, fault tree analysis, pFMEA. Ensure all change control activities are performed in a compliant manner, especially those changes that require customer notification and/or approval prior to implementation. Establish sampling plans based on sound statistical rationale and based on risk. Develop and validate production processes and test methods with demonstrated, documented capability. Ensure first article reports on all new molds are completed per local requirements and in accordance with customer expectations which includes full dimensional evaluations as required. Demonstrated application of root cause analysis tools to resolve problems in a timely manner when they arise. Telecommuting is an option. Some travel to Westfall Technik offices may be required.

Minimum Requirements: Bachelor's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or a related quantitative discipline, and six (6) months of experience in the job offered or in any occupation in related field.

Special Skill Requirements: (1) Minitab, (2) Visio; (3) Statistical Analysis, (4) FMEA, (5) Root cause analysis, (6) Cleanroom Monitoring ISO-14644, (7) Six Sigma, (8) Lean manufacturing, (9) Deviation Handling. Any suitable combination of education, training and/or experience is acceptable. Telecommuting is an option. Some travel to Westfall Technik offices may be required.

Salary: $82,784.00 - $95,000.00 per annum.

Submit resume with references to: Req.#: 22-17181 at: ATTN: Amanda Tolleson, riverside.recruitment@westfall-technik.com.

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