||Quality Engineer II - Equipment
The incumbent applies systems engineering and quality assurance principles and techniques to the product development lifecycles. The position will focus heavily on complaint processing activities. The position may also perform system testing for NxStage medical
devices and other business systems that support the Quality System.
• Lead effort to investigate and process medical device complaints and maintain open complaint level to acceptable levels.
• Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.
• Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
• Process non-conforming material reports including MRB dispositioning.
• Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
• Develop, implement, and/or maintain instructions/methods for inspecting, testing and evaluating product conformance to specification.
• Conduct internal audits for evaluation of compliance with the Quality System Regulations.
• Support Engineering in the development, testing, verification, validation and commercialization of new products.
||Education & Qualifications:
• B.S. in Engineering Related Field
• 3+ years related quality assurance, quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
• Experience investigating and processing medical device product complaints
• ASQ certification a plus.
• Intermediate knowledge of FDA Quality System Regulation 21 CFR Part 820.
• Good organizational, attention to detail and follow-through skills
• Excellent verbal and written communication skills
• Ability to interface with multiple groups in the organization.
• Systems - Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.
• Willingness to contribute to other departments as necessary
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
- Please view Equal Employment Opportunity Posters provided by OFCCP
- 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
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