|
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
http://sqa.fyicenter.com
| 