QUALITY ENGINEER

Responsibilities

• Serve as a multi-functional team member establishing quality requirements and providing guidance for sustaining engineering projects.
• Lead or support Risk Management (in accordance with 18014971) evaluation of current products as well new products being developed.
• Develop and implement quality improvement programs
• Review validation protocols for effectiveness and compliance to Corporate Guidelines.
• 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.
• maintain documentation and compliance.
• Serve as a multi-functional team member establishing quality requirements and providing guidance for sustaining engineering projects.
• Lead or support Risk Management (in accordance with 18014971) evaluation of current products as well new products being developed.
• Develop and implement quality improvement programs
• Review validation protocols for effectiveness and compliance to Corporate Guidelines.
• 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.

Qualifications

Responsible for assuring that 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 incumbent will be responsible primarily for QE support of Client Sustaining Engineering activities and general Quality Assurance tasks related to Client products as needed. 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 Quality Engineering Manager.

Regards,

Monil Patel

Technical Recruiter

Integrated Resources, Inc

(732) 844-8747 Ext.338

monil @irionline.com