US-CA-SanFrancisco: Quality Assurance Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 25-May-2010

Quality Assurance Engineer

# Participates as the Quality representative on cross-functional development teams and supports development activities as they relate to specification development, sample sizes, and test plans

# Support incoming material and supplier quality by determining the Quality requirements for new materials and vendor approvals, investigating non-conformances and providing supplier feedback

# Collaborate with engineering and manufacturing to ensure effective implementation of process and inspection improvements.

# Support manufacturing operations and provide guidance in sampling plans, statistical process control, min/max studies, and evaluation of control charts.

# Takes the lead on returned product analysis, reporting requirements and trending.

# Oversee the review of lot history records and final product release, including review of sterilization records.

Qualifications/Education/Experience Requires a team player with a bachelor’s degree (or equivalent QA/QE medical device experience) in engineering or life sciences and 3-5 years experience in the medical device industry. Must be able to make decisions related to product quality and compliance. Must be able to provide and implement solutions to quality problems. Requires the ability to understand the impact of QSR’s, GMP’s, ISO 13485, and MDD requirements. Must have effective written/oral communication skills. MS Office, Excel, Statistical software. The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job. Limited travel (<10%) required.

To apply for this position, please visit this Website.

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