Description:

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The Quality Validation Engineer is responsible for the quality control of our product design and manufacturing process control. He/she understands the Quality System Regulations and ISO standards (13485 and 21 CFR) and facilitates improvements to the quality system while providing technical quality engineering support to research and development and manufacturing. The Quality Validation Engineer serves as a Quality member on new product development (R&D) and provides technical support or leadership of quality deliverables. This position is responsible to support R&D and Operations during all product development phases and develops process qualification activities, statistically sound sampling plans and process control plans including inspection/ test method development. Additionally, this position is responsible for validation documentation of equipment, processes, methods, and software such as Master plans, IQ/OQ/PQ and Final Reports. Executes validation protocols and writes final reports. Coordinates necessary support personnel to ensure efficient and effective execution. Manages each phase of the validation as required across shifts to meet internal and external customer needs and ensure the exercise is performed and closed in a compliant manner.1.\tUse of statistical tools to facilitate design verification test sample size and test method validations.2.\tLead Risk Analysis (FMEA-CA Design/ Process) meetings and generate final reports and actions requirements. 3.\tPerform analyses of failed material in order to determine the root cause. Implement appropriate corrective actions. 4.\tWork on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.5.\tReview and approve document changes (process and design).6.\tAssist R&D in test method development and conduct test method validation.7.\tParticipate on internal quality audits.8.\tDevelop and implement quality systems in compliance with ISO certification.9.\tReview and approve receiving inspection requirements and sampling plans for components. Develop and improve QC inspection and testing method as needed.10.\tBackfill quality review, QC testing, receiving inspection and product release activities as required.11.\tSupport the implementation of overall company validation strategy12.\tPerform role to ensure all validations are in compliance with company policies and procedures13.\tAssess, process and circulate protocols and final reports for review and approval14.\tExecute each phase of the validation and/or solicit support to ensure adherence to the protocol requirements.15.\tReport and document Protocol exceptions16.\tLiaise with scheduling/planning and sales as required to ensure communication and documentation flow throughout the process.17.\tProvide feedback to appropriate personnel on the validation activities and project status.18.\tActively communicate and share knowledge as required with the process engineering group.19.\tWork in a safe manner in compliance with relevant policies for safety.

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Additional Skills & Qualifications:

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Experience and Knowledge in Good Manufacturing Practices (GMPs) and Quality Systems and ISO-13485.Propose innovative practices to ensure processes are efficiently validated and product could be available for sale to the appropriate market.Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, ISO13485, etc.).Proficient in knowledge of variety of testing equipment (including Introns, pin gages, snap gages, micrometer, caliper, etc.).Proficient technical writing skills and use of documentation programs (e.g. Office Windows, Excel, Access, Power Point, etc.).Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma.ASQ Certified Quality Engineer Preferred.

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Experience Level:

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Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.