1+ months

Quality Engineer

Kelly Services
Winston-Salem, NC 27199
**Kelly Engineering** is currently recruiting for a **(Direct Hire) (Quality Engineer)** job located in **Winston Salem, NC** **.**

**Primary Responsibilities:**

+ Performs and documents Quality Plan (QP) assessments.

+ Performs and documents timely Corrective and Preventive Actions (CAPA) investigations.

+ Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation.

+ Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines.

+ Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regards to non-conformances, supplier changes, etc.

+ Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols).

+ Performs statistical data analysis utilizing statistical software (Minitab and Excel).

+ Develops and implements statistical methods and designs experiments to support process control and process/product improvement.

+ Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes.

+ Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.).

+ Supports development and implementation of methods for sampling, inspection, testing and evaluation of products.

+ Interfaces with customers to provide technical support for our products/complaints/change control.

+ Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.)

+ Supports customer and/or third party audits as required.

+ May be trained as an auditor and perform quality audits.

+ Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOPs, Work Instructions) to successfully accomplish job requirements.


+ Bachelors degree in one or more of the following - Life sciences Engineering, Engineering, Quality, Life sciences.

+ 1 - 3 years- including co-op experience.

+ Experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering.

+ Knowledge of applicable regulatory standards, specifically ISO 13485, FDA 21 CFR Part 820, 810, and 811 and ISO 9001 (if applicable) or possess the ability to understand and enforce the practices.

+ Able to read, analyze and interpret common scientific and technical journals, financial reports and legal documents to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.

+ Strong problem solving and analytical skills, with concentration on risk analysis;

+ Demonstrated project organizational skills required.

+ Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables.

+ Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities.

+ Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab).

+ Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management and process control.

**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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: 2020-10-26 Expires: 2020-12-26

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Quality Engineer

Kelly Services
Winston-Salem, NC 27199

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