20 days old

Quality Assurance Engineer

Kelly Services
Phoenix, AZ 85067
**Sr. Quality Assurance Engineer Phoenix, AZ**

Immediate opportunity for a **Sr. Quality Assurance Engineer** in **Phoenix, AZ** who will be responsible for the analysis and resolution of production issues through collaboration with engineering and material procurement teams. Perform monitoring of process data and analysis of trends, financial results, and customer feedback. Exhibit a commitment to quality first culture, compliance, and continuous improvement through the implementation of projects which optimize production, inspection, and quality system processes.

**Skills & Experience:**

+ Excellent analytical, interpersonal, and organizational skills.

+ Effective interpersonal communications skills.

+ Possesses understanding of core process methodologies and problem-solving techniques.

+ Possesses ability to understand engineering drawings.

+ Drives for results through timely decision making and the ability to prioritize, plan and measure work.

+ Resolves conflicts and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome.

+ Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization; uses direct persuasion to convince and influence others.

+ Possesses the ability to interact with diverse internal customers in an effective manner.

+ Communicates information verbally and in writing in the appropriate language and format according to the audience. Must be able to generate, follow and explain detailed quality requirements and inspection procedures.

+ Must be able to plan, organize and implement multiple concurrent tasks.

+ 2+ years experience as a Quality Engineer in a manufacturing environment, preferably medical device.

+ Experience working in a manufacturing environment.

+ B.S. in engineering, or related discipline.

**Preferred Experience:**

+ Certifications in Quality Engineering, Auditing, and/or Green Belt or higher.

+ Extensive experience investigating / processing non-conformances.

+ Quality Systems knowledge and understanding of ISO 13485 and/or equivalent.

+ Knowledge of writing Excel Macros, compiling data, graphing, VBA, pivot tables, queries.

**Work Environment:**

+ Various environmental conditions - office, production floor, warehouse, lab, customer sites (e.g., hospitals).

+ May support multiple manufacturing sites.

+ While performing the duties of this job, it may be required to stand, walk, or sit occasionally for long periods of time. It may also be required to use hands or fingers to handle, or feel objects, reach with hands and arms, balance, stoop, kneel, or crouch.

+ May occasionally lift and/or move up to 30 pounds (seek assistance for greater amounts).

+ Long periods of computer work.

+ The noise level is usually moderate.

+ May be exposed to hazardous materials. Consult MSDS in work area.

+ Exposure to used medical devices.

+ Exposure to cleaning agents.

+ Protective equipment is required, as indicated by area procedure.

+ Subject to changes in procedures or work environment.

+ May need to operate small hand tool, inspection equipment and common office equipment.

+ May require short term assignment in Lakeland, Florida (on-the-job training).

+ Future travel: 10%.

+ Operate in a fast-paced environment, sometimes requiring extended work hours.

**Essential Duties & Responsibilities:**

Production Quality Management Issue Analysis and Resolution:

+ Perform robust root cause analysis of production issues, implement appropriate containment, and drive corrective action.

+ Coordinate with Design Engineering, Regulatory, Manufacturing Engineering to conduct risk analysis of non- conformances found in manufacturing.

+ Coordinate with division and manufacturing engineers as well as material teams to drive collaboration and communication for issue resolution.

+ Monitor / analyze production performance trends for key quality metrics and establish appropriate control measures.

+ Drive detection and prevention of non-conformances to improve business results through reductions in scrap and rework costs in addition to assurance of a positive customer experience.

+ Conduct activities associated with the investigation and resolution of customer complaints.

Production Quality Management Process Improvement:

+ Evaluate and improve quality inspection methods and fixtures to improve reliability and repeatability of incoming, in-process, and final QC.

+ Evaluate production/inspection equipment, processes, and procedures to ensure accuracy and compliance to regulatory and quality system requirements.

+ Drive changes to procedures, as necessary.

+ Analyze the risk associated to non-conforming inspection equipment and take action on affected product.

Operations and Quality Control (QC) Efficiency:

+ Facilitate resolution of Material Review Board (MRB) issues leading to reduction in number of components / products in MRB.

+ Optimize Companys incoming, in-process, and final QC inspection plans / requirements / fixtures to efficiently detect defects in early production stages.

+ Ensure timely resolution of non-conformances and product ship holds.

+ Partner with Operations and Division engineering to develop solutions to non-conformances.

+ Participate in validation activities.

+ Work with Strategic Sourcing and Purchasing as the Supplier Quality resource.

+ Support supplier change processes and supplier improvements.

Continuous Improvement:

+ Identify and lead implementation of process / procedure / system improvements. For example, component qualification process, skip lot process, supplier change process, etc.

+ Lead and / or support Corrective Action Preventive Action (CAPAs) that can impact the Quality System and / or product quality and drive reliability improvement.

+ Provide support during internal and external audits as required.


+ 1 year contact (to possible perm) opportunity

+ Pay Range: $50-70/hr. (DOE)

+ Schedule: M-F, 40 hrs./wk. (1 st shift)

**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: 2022-07-22 Expires: 2022-08-22

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Quality Assurance Engineer

Kelly Services
Phoenix, AZ 85067

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