8 days old

Quality Engineer

Kelly Services
Reedsville, PA 17084
**Quality Engineer Direct Hire - Relocation Expense Available**

Kelly Engineering Resources has an outstanding **direct hire opportunity for an experienced Quality Engineer** that is competent with **statistical analysis and has a record of data driven decision making.** Our customer is a high volume component manufacturer located in central Pennsylvania. You would be joining a growing team that created this opening due to an internal promotion. In this role, you will maintain the QMS through process validation, continuous improvement, and CAPA in support of plant quality and New Product Introduction.

**You will provide:**

+ Quality system support through internal and external customer engagement.

+ Lead and support continuous improvement for product and processes.

+ Support plant functional areas such as engineering, operations, and maintenance by conducting data and document review/approval as it pertains to the plant quality control systems.

+ Support investigation and root cause analysis, CAPA, documentation management, and change management.

**Your Primary Functions:**

+ Aides in ensuring FDA regulatory and ISO standards compliance as applicable during New Product Intro (project management and transition to manufacturing)

+ assuring customer specification and inspection methods are understood and complied with throughout engineering projects into production.

+ Assists as necessary in the development and execution of procedures for product and equipment Process Validations.

+ Conducts and participates in ISO 13485 audits as necessary.

+ Serves as support to metrology improvement and needs for the laboratory team.

+ Works independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation (SOPs, Work Instructions), test methods, and any other necessary documentation.

+ Supports the QMS through review and approval of product / process investigations (deviations, OOS), change control, CAPA, and other quality systems documentation as necessary.

+ Assists in the management of quality metrics/KPIs and their review through trend analysis and interpretation.

+ Leads and supports root cause failure analysis and implementation of corrective and preventive actions to preclude reoccurrence.

+ Primary support to plant continuous improvement by evaluating products, processes, or materials to develop control or improvement strategies intended to improve the internal and customer experience.

+ Other duties as assigned.

**Qualifications to be Successful:**

+ Bachelors degree in engineering or related scientific discipline or relevant experience in lieu of degree.

+ Three to Five (3-5) years of experience working in Quality Assurance of a manufacturing facility, high volume production a plus.

+ Required Working knowledge:

+ SPC, sampling/auditing/reading blueprints, dimensioning and tolerance

+ A variety off the Six Sigma/continual improvement and quality tools including any of the following:

+ Control charts

+ Capability studies


+ Regression analysis

+ Histograms

+ Fishbone charts

+ Corrective Action & Root Cause Analysis / Preventive Action / Continual Improvement.

+ Risk management techniques/tools such as FMEA development, PPAP, PFMEA, etc.

+ Quality systems software to manage investigation, CAPA documentation, batch data, and change control.

+ 2 years experience in a cGMP compliant environment or ISO certified industry highly preferred (ISO 9001, IATF 16949, AS 9100 are encouraged to apply)

+ Working knowledge of ISO 13485 or 21 CFR 820, and 21 CFR 210 & 211 a plus

+ Required Verbal & Written Communication Skills:

+ Presentation - prepare work instructions & numerical reports and verbally present to internal staff and customers

+ Interface with customers via written, verbal, or personal means in order to ensure a clear understanding of all requirements.

+ Write technical reports to be submitted to customers and other departments is required

+ Write technical protocols, analyze information, and report results.

+ Write presentations include developing numerical data

+ Accurate communication to individuals and to the team to develop a cohesive group.

+ Lead project teams consisting of members with diverse roles and backgrounds.

+ Strong computer skills including advanced skills for data reporting and presenting data such as Excel chart creation, PowerPoint for presentations, statistical software highly preferred

+ Minitab proficiency a plus

+ Continual demonstration of professional development and the application to plant activities.

+ The ability to work with and maintain information of a highly confidential and sensitive nature.


**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: 2021-04-07 Expires: 2021-05-08

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Quality Engineer

Kelly Services
Reedsville, PA 17084

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