Position : Quality Engineer (Non-Light Industrial)
Location : Franklin Lakes, NJ
Duration : 12+ Months Contract
Start Time :08:00 AM
End Time :05:00 PM
Total Hours/week : 40.00
· Knowledge of 21 CFR Part 820 (Subpart C – Design Controls) is preferred. Responsible for assuring quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.
· The position requires a self-motivated, self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills. In addition the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of sustaining engineering and/or new product development projects and assume personal responsibility for the successful completion of all tasks within the realm of quality engineeringresponsibilities.
· The Quality Engineer reports to the Associate Director, Quality Engineering.
• Serve as a multi-functional team member establishing quality requirements and providing guidance for product design/development (e.g. sustaining engineering) projects.
• Lead or supportRisk Management evaluation of current products as well new products in accordance with ISO 14971.
• Review validation protocols for effectiveness and compliance to Corporate Guidelines.
• Develop and implement quality improvement programs
• Assist with Complaint Investigations involving the design center and manufacturing sites, as necessary.
• Assist with drafting, reviewing and approving Non-Conforming Material Reports.
• Assist and/or generate field issue investigation (Situation Analysis) reports and assure timely close out of all required actions associated with the process.
• Assess current operations for quality and compliance.
• Develop methods to measure, validate and assure quality standards are achieved for applicable product lines.
• Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
Education: Bachelor's Degree in Engineering or Life Sciences
Licenses Or Certifications: Six Sigma Certification and Certified QE
Preferred Experience: 1-3 Years experience i n Medical Device Industry