US: QA Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 04-Apr-2013

you will work on cross-functional teams to address product issues, define and implement effective corrective actions, and monitor post-implementation effectiveness. The ideal candidate will:* Be passionate about quality system processes and their continuous improvement in support of state-of-the-art implantable medical devices * Be energized by working for a world-class manufacturer and collaborating on cross-functional teams * Recognize the importance of building and maintaining strong interpersonal relationships Responsibilities include:* Making operational improvements * Performing product development and design control activities * Enhancing quality systems (including software implementation and validation) * Performing compliance audits * Selecting and approving suppliers * Training, teaching, coaching, and mentoring associates Other responsibilities may include:* Advising various teams (e.g., raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.) * Developing procedures and initiating change documentation in support of new and existing products * Developing quality reports to support assessments of quality-system effectiveness * Reviewing complaints

JOB REQUIREMENTS: Required Job Qualifications* At least 5 years' experience in a Quality Assurance role in the medical-device, pharmaceutical, biotech, or other regulated industries * Strong knowledge of/experience with quality system implementation and maintenance * Sound knowledge of FDA medical-device quality system regulations and ISO medical-device standards * Excellent written and oral communication skills * Strong interpersonal skills * Conflict resolution skills * Ability to: * Work independently, as well as part of a diverse team * Set and meet aggressive timelines

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com