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Quality Engineer
Ref No.: 17-05815
Location: Franklin Lakes, New Jersey
Position Type:Contract
Start Date: 09/25/2017
Job Category:Non-IT Engineering
The incumbent will primarily be responsible for Quality Engineering support for PAS product design/development (i.e. Sustaining) Engineering activities and general Quality Assurance tasks related to PAS products, as needed. 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 engineering responsibilities. The Quality Engineer reports to the Associate Director, Quality Engineering. 

Responsibilities: • Serve as a multi-functional team member establishing quality requirements and providing guidance for product design/development (e.g. sustaining engineering) projects. • Lead or support Risk 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: Bachelors degree or Technical Degree required.