Quality Engineer

Job description (Tasks/Responsibilities):

Initiates and coordinates quality programs to prevent or eliminate defects in new or existing products; manages analysis of mechanical and software products and systems to determine cause of failure and corrective action needed by performing the following duties.

Acts as primary quality representative on multiple new product development teams. Responsible for review and approval of design documents including development plans, specifications, risk assessment, and verification and validation activities. Develops methods to identify software/hardware quality issues and communicates them to Engineering to rectify problems. Reviews technical problems and recommends solutions to problems or changes in procedures. Manages supplier quality assurance program. Coordinates the approval of new vendors with Engineering and Operations. Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards. Carries out supplier quality surveys and audits jointly with Purchasing. Manages the Material Review Board process. Identifies actions required to address problems regarding nonconforming material. Manages failure analysis program including the analysis of data such as customer feedback, and internal reports, specifications, and manuals to identify failure modes and the determination of further actions and resolutions. Identifies the need for corrective and preventive actions in conjunction with other company personnel. May be required to travel to and interact with customers, vendors and contract testing services. Produces data, reports and metrics for review. Provides historical failure analysis data to Engineering for new product development projects. Assists in the preparation of quality system documentation. Assists in the preparation of regulatory submissions and technical files. Performs internal quality system audits. Other duties may be assigned.

Skill Requirements:

Knowledge of quality and statistical processes, including quality tools and their application. Ensures that he/she is assigned are completed accurately and on time. Works independently to identify scope all aspects of assigned tasks and complete them without monitoring. Ensures his/her work and the work of others supports the departmental goals and objectives. Has the functional and technical knowledge and skills to do the job at a high level of accomplishment. Adheres to an appropriate and effective set of core values and beliefs during both good times and bad. Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment.

Education Requirements:

Four year degree. Bachelor's degree (B. S.) in Mechanical, Electrical or Computer Engineering from four-year college or university preferred. Work experience in a related field preferred. Professional Engineering Certification (P.E.) a plus. Minimum of one year of experience working in an organization regulated by the Food and Drug Administration (FDA) or certified to an internationally recognized quality system.

Location (City/State):

Pittsburgh, PA

Company Description:

BodyMedia brings together an international team of engineering, design, manufacturing, sales and marketing professionals. The company is looking for new hires to help us develop and deliver our groundbreaking solutions for metabolic disorders and help turn the tide on the obesity, diabetes and CVD. BodyMedia rewards our employees with competitive compensation packages and comprehensive benefits. BodyMedia has consistently been recognized for our leadership in innovation and a strong team culture that allows employees the opportunity to lead and the freedom to grow.