Quality Engineer

Confidential Company  •  Franklin Lakes, NJ

Less than 5 years experience  •  Biotech/Pharma

$80K - $90K
Posted on 10/11/17 by Edwin George
Confidential Company
Franklin Lakes, NJ
Less than 5 years experience
Biotech/Pharma
$80K - $90K
Posted on 10/11/17 Edwin George

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

Qualifications:                

·        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.

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 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

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