Supplier Quality Engineer Job in Shenandoah, Virginia US

Our client is ranked among the top life science companies providing outsourced design and manufacturing solutions for surgical devices and scientific applications. Due to the company's growth we are looking for a Supplier Quality Engineer to join their team at their Headquarters in Shenandoah, VA.

Some of the benefits to you:

·         Great Place to Work! – In 2011, we our client was named one of the top ten “Best Companies to Work For” by Medical Device and Diagnostic Industry magazine. From their company culture to their benefits program, our client is an awesome place work.

·         Stability Financial Strength – As premier metals manufacturing company focused on new medical technologies, they have a reputation as the market expert for improving product performance.  They are financially strong and well positioned for continued growth.

·         Career Growth – Our client considers their employees to be our most valuable asset, and as such they are committed to providing you an environment where you will be appreciated, respected, and challenged – you will have the opportunity to grow professionally.

·         Make a Positive Impact – “Do the right thing” is more than just a corporate motto for our client; it’s their guiding principle and way life.  You can be proud of the fact that what you do every day will help save lives.

To be considered for the exceptional career opportunity you must have at least the following:

·         A Bachelor’s Degree in a technical field - Engineering or Quality related field desired

·         At least 2-3 years experience in a quality assurance role using Statistics, SPC, Geometric Dimensioning/Tolerancing; and Sampling.

 

Other Qualifications:

·         Experience with regulatory requirements and ISO Certification inspections (FDA/ISO 13485 desirable)

·         Must be adept in use of computer software for the analysis of data

·         Quality Engineering Certification (CQE)  equivalent preferred

·         Six Sigma, Lean Manufacturing, and/or other manufacturing related certifications a plus

 

Job Description

Position Purpose:

 

The Quality Engineer works with operations and product development teams to ensure compliance to the Quality Manual and other procedures from product concept through market introduction. This position assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.

 

Position Responsibilities

 

Supplier Auditing and Development

·         Coordinates with customers and suppliers relating to quality performance, trends, and corrective action. Verifies compliance and effectiveness of the quality system by performing supplier audits and surveys.

·         Devises and implements methods and procedures for inspecting, testing, and evaluating the precision, reliability and accuracy of products and processes of suppliers.

·         Ensures that project and/or process control documentation is compliant with requirements and/or contracts.

·         Initiates programs to improve supplier performance and lead supplier development

·         Works with suppliers to refine and enhance products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to assure quality of goods and services provided

·         Ensures that nonconforming material is dispositioned in a timely manner and analyzes defect trends in order to initiate appropriate corrective action.

·         Performs Quality Systems and Process Audits of suppliers including reporting, follow-up and closure of non-conformances

 

Quality Engineering Support Duties

·         Provides support to ensure company compliance with FDA Quality System Regulations and ISO 9001:2008 and ISO 13485 standards.

·         Actively participates in internal audits, management review and other activities covered under the Cadence Quality Manual, Policies and Procedures.

·         Provides customer related quality and regulatory inquiries support.

·         Actively participates in the development of the Manufacturing Supply Base including surveillance audits and Corrective Action closure.

·         Compiles and writes training material and conducts training sessions on quality control activities.

·         Provides quality engineering direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost effective manner.

·         Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.

·         Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.

·         Performs measurement system analyses to evaluate test and inspection equipment.

·         Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.

·         Assists workers engaged in measuring, testing, and tabulating data concerning quality and reliability.

·         Other duties as assigned.

 

Physical Demands

Candidates should be able function in both office and manufacturing environments of a multi-location corporation. The majority of time will be spent in the office environment. Occasional travel may be required. Must be able to tolerate sitting and working with a computer for extended periods of time. Fine motor skills are utilized when typing and using various office machines. Requires clear verbal communication, hearing ability and clear vision or reasonable alternative. Must be able to safely and effectively move throughout our facility and interact with employees.