Join a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, company develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electro-chemiluminescence detection technology.

This Quality Engineer reports to the Director of Quality Assurance. The QA will facilitate the development, implementation and monitoring of quality programs, plans, SOPs and policies that ensure that the development, manufacture and distribution of products is in compliance with FDA regulations, ISO 9001, ISO 13485:2003, and other regulatory requirements as applicable. Specific duties will include as described below:

Development and implementation of sampling plans for in-process and final testing, inspections, and validations.

Participation in FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.

Participation in engineering change board meetings and product design reviews.

Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.

Assisting in developing & maintaining training programs and records.

Application of the principles of performance evaluation and prediction to improve product/systems safety, reliability and maintainability.

Working with a cross-functional team to plan and execute reliability test protocols on new and existing systems.

Planning, tracking and analysis for reliability testing and field failures (including mathematical modeling to determine system reliability and MTBF/MCBF).

Participation in hazard analysis, FMECA, and risk mitigation.

Implementing root cause analysis and addressing CAPA entries.

An individual qualifying for this position will have a BS or MS degree in an engineering discipline with experience in medical devices, in vitro diagnostics, life sciences or a related industry. Experience utilizing statistical process control and process capability techniques in a manufacturing environment is a plus. ASQ certification (CQE, CRE, CQA) is preferred. The candidate should have strong analytical, communication and interpersonal skills.

Send a word resume to jthompson@tescareers.com jthompson@tescareers.com

Jeff Thompson

TES, Inc

440-266-0022 ext 104