SQAFYI - Software QA Resource - FYI

US: QA / RA Senior Engineer

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

QA / RA Senior Engineer

Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures Facilitates and completes root cause analysis investigations when design challenges are encountered Works with the project leader, systems engineers, and design engineers to plan and hold robust design reviews

Actively participate and/or lead Design History File audits and follow-on remediation efforts as required Provides leadership to educate cross-functional partners to ensure proper implementation and use of quality tools and procedures as required Enables rapid and effective correction of quality/regulatory problems in a manner that prevents reoccurrence

Participates on various continuous improvement/process improvement teams Develop, modify, or review for approval any procedure related to product development

Proficient with Quality System Regulations, Medical Device Directive, and ISO Quality System Standards Strong understanding of ISO 14971; safety by design; Risk Management structure Demonstrated ability to work and perform in team environments and effective interpersonal / influencing skills Demonstrated high attention to detail Excellent analytical decision making and problem solving skills Proven ability to resolve issues and participate in process improvement activities Track record of successful business and customer orientation

10+ years of Quality/Regulatory experience required, 15+ desired 8+ years of experience in medical device industry (class II, class III) or other regulated industry required, 12+ desired Experience in New Product Development / Design Controls required Experience with direct or indirect management of teams B.S. in Engineering or other technical degree required; ASQ certifications desired

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US: QA / RA Senior Engineer