JOB REQUIREMENTS: Quality Engineer/ Sr. Quality Engineer - QUALI003779 DESCRIPTION/RESPONSIBILITIES: This position is responsible for providing Quality Engineering and Technical Support for operations, sustaining engineering, R&D, and New Product Introduction. This position would include supporting a wide array of activities related to Change Control, NCR/CAPA, Quality operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. Key Responsibilities: Change Control: * Support/Lead Change Control Activities (Operations, Engineering, Design, etc.). Support updates to operating procedures, process, product / specifications, risk management files, etc through the Change Control process. * Support/Lead 3rd party supplier management activities such as review 3rd party design control activities. Support NCR and CAPA: * Support / lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting. Design Control: * Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new. products. Risk Management: * Support / Lead Risk Management activities including review and coordination of quality activities related to risk. Inspections: * Support/Lead with federal, state, and local regulatory officials during regulatory inspections. * Support/Lead in internal and vendor quality system audits as applicable. Quality Initiatives: * Identifies and implements new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. * Works with manufacturing and other functional groups on manufacturing regulatory compliance issue * Support/Lead training program by developing, coordinating, and delivering assigned training tasks. Adherence to Regulations: * Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices. Management: * For those who manage or supervise staff: Manage staff including interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor\'s legal duty to furnish information. 41 CFR 60-1.35(c) Equal Opportunity Employer-minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity ***** OTHER EXPERIENCE AND QUALIFICATIONS: Education: Sr. Quality Engineer * BS in a Physical Science or Engineering, or equivalent experience. Required * ASQ Certification as a Quality Engineer or equivalent. Preferred * BS Engineering. Preferred Quality E gineer * BS in Engineering or equivalent experience. Required Experience: Sr. Quality Engineer * 5 years\' work experience at least 3 years in Quality in Medical Device. Required * Experience with electromechanical device software and hardware validation. Preferred Quality Engineer * 2 years in Medical Device or similar experience. Required * 2 years in a quality role. Preferred * 2 years working with electromechanical devices. Preferred * ASQ Certification as a Quality Engineer or equivalent. Preferred Knowledge, Skills and Abilities: * Knowledge of Regulatory Requirements: Deep understanding of regulatory requirements for medical devices and pharmaceutical organizations. Familiar with ISO 13485, FDA Quality System Regulations, GMPs, and other international regulations. * Knowledge of regulatory requirements for medical device / pharmaceutical organization. * Strong technical and general problem-solving skills, with specific experience in NCR/CAPA processes. * Audit Experience: Proven ability to perform internal and/or supplier audits. * Familiar with ISO 13485 Quality System Standards, ISO 14971, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. * Understanding of IEC 60601, 62304, RoHS, WEEE. ***** APPLICATION INSTRUCTIONS: Apply Online: https://ars2.equest.com/?response_id=1e669fc2fe432b58cd7061bf131e7762 Other: Applicants ONLY to apply via URL link provided!