21 days old

Quality Engineer

Kelly Services
San Angelo, TX 76909
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Quality Engineer for a long-term engagement at one of our Global Medical Device clients in **San Angelo, TX** **.** This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.

**Pay $35 per hour**

**Full benefits**

**1 year contract**

**Position Overview**

As an **Quality Engineer** placed with KellyOCG you will work under the direction of the Quality Manager Operations and with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, you will work closely with business partners utilizing various Quality Engineering tools in the development and manufacture of new products as well the maintenance of current products, materials, and processes.

You will function as a quality representative on multi-functional product development teams in matters relating to Quality Engineering and in day to day activities supporting manufacturing lines, operator certification program, incoming and finished good inspections, and CME environmental monitoring, all in accordance with applicable regulations, written specifications, and quality standards.

**Position Responsibilities**

Under the direction of the Quality Manager Operations and in accordance with all applicable federal, state, and local laws/regulations, procedures and guidelines, this position:

+ Will support design control and process validation activities for new and change product efforts.

+ This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.

+ This individual will lead and ensure the development of comprehensive risk management plans and operating procedures for the product and process.

+ The Quality Engineer will ensure effective and comprehensive quality strategies.

+ Will assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action.

+ This individual will ensure the development and validation of appropriate test methods for design and manufacture of products and components.

+ The Quality Engineer will track/trend quality issues over time and generate reports to management and across sites.

+ This Quality Engineer will provide guidance to project teams, suppliers, and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.

+ Will assess, implement, and monitor process capability for continuous improvement.

+ This Quality Engineer may be responsible for leading cross-functional work teams and/or managing QA technicians to include direct daily supervision, performance appraisal, behavioral discipline, professional development and on the job training.

+ Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.

+ Provide support to Clients process excellence initiatives including Six-sigma & lean thinking.

+ Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.

+ Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

+ Responsible for communicating business related issues or opportunities to next management level

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

+ Performs other duties assigned as needed

**Required Qualifications**

+ A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science, or a related field is required; an advanced degree is an asset.

+ A minimum of 5 years Quality Engineering work experience is preferred, with experience in the medical device, pharmaceutical or other highly regulated industry also preferred.

+ Knowledge of ISO and/or cGMP regulations is preferred.

+ New product development experience is preferred.

+ Supplier Quality Engineering experience is an asset.

+ Sterilization process experience is an asset.

+ General knowledge in Quality Systems Regulations (QSR) is an asset.

+ An ASQ certification (CQE, CQM, CRE or CQA) is an asset.

+ Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.

+ Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.

+ Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs.

+ Good communication and presentation skills will be needed.

+ Maturity and ability to display a high level of professionalism is required

**Important information:** This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

To learn more about KellyOCG and our Managed Solutions expertise, visit us at **/Solutions/Business-and-Professional Services**

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

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook ( , LinkedIn ( and Twitter ( .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (
Posted: 2021-05-28 Expires: 2021-06-28

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Quality Engineer

Kelly Services
San Angelo, TX 76909

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