Company DescriptionIRI believes in commitment, Integrity and strategic workforce solutions.Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.Job DescriptionResponsibilities: • 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. QualificationsQualifications: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. Additional InformationRegards,Monil PatelTechnical RecruiterIntegrated Resources, Inc(732) 844-8747 Ext.338monil @irionline.com