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28 days old

Quality Assurance Engineer

Kelly Services
Flower Mound, TX 75027
**Quality Assurance Engineer**


What's next for you? This great job. Kelly is looking for a dynamic **Quality Assurance Engineer** for our top biomedical client in Flower Mound, TX. The ideal candidate will have a bachelors degree in engineering and 6+ years experience in Quality Assurance as well as ISO14971 compliance. This is a one-year contract role with possibility of extension. This will be an on-site role. **All candidates must be local to the DFW area and willing to commute.**


*** MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) *** NO C2C, 1099, etc. ***


+ **Shift: 8:00am to 5:00pm**

+ **Location: Flower Mound, TX**

+ **Pay: Commensurate with Experience**


**Scope:** The QAE supports and executes design for manufacture and assembly through technical leadership in quality assurance, design control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. Support the development and characterization of processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQAs, CTQs and MSAs to enable process risk identification, process characterization, capability and robust process control. Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Provide Quality engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.


**In this role you will:**


+ Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA.

+ Ensure all Risk Management outputs comply with ISO14971.

+ Support Design team to complete CQA/CTQ identification and inputs to dFMEA.

+ Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.

+ Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.

+ Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.

+ Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.

+ Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.

+ Influence processes towards validation versus manual verification, where possible.

+ Support the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Suppliers Quality Systems can complete process characterization and develop highly capable processes that are scalable and meet Stryker expectations.

+ Provide Quality input to influence the proper selection of suppliers.

+ Support implementation of supplier certification.

+ Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.


**Education and requirements:**


+ Requires a bachelors degree in Engineering or equivalent

+ Minimum of 6+ years Quality Engineering experience. 6+ years Quality Control preferred.

+ Proficient understanding of Med Device manufacturing processes

+ Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).

+ Familiarity with ISO14971

+ Excellent communication skills and attention to detail

+ Has a strong understanding of engineering and quality practices & methods

+ High level of PC skills.

+ Must be proficient with Microsoft Word, Microsoft Excel, PowerPoint and One Note.

+ Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.

+ Working knowledge/experience of statistical techniques Highly developed problem solving and strong analytical skills

+ Builds strong relationships by fostering open communications, respect and trust.

+ Strong team player and acts with a customer service/stakeholder focused approach

+ Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.

+ Manages change well and adopts a continuous improvement orientation to the role

+ Ability to be the voice of Quality when dealing cross functionally. Will take the lead in discussions / meetings to ensure the correct outcome.


**Why Kelly?**


As a Kelly employee, youll have access to world-class perks, including:


+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ *Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Exclusive online employee community

+ Employee assistance program available at no cost

+ Corporate discounts

+ Transportation Spending Accounts


*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.


**Apply Today!**


***Important information: This position is recruited by a remote, national, Kelly office, NOT your local Kelly branch. Applicant must have a legal right to work in the US without sponsorship or VISA transfer for this position. There is no relocation budgeted for this position. All candidates must be local to the area at time of application.**


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-27 Expires: 2022-06-27

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Quality Assurance Engineer

Kelly Services
Flower Mound, TX 75027

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