Quality Assurance Engineer

3 weeks ago

New York, United States The Metrix Company Full time

The Metrix Company, a leading medical device manufacturer, is seeking an experienced Quality Assurance Engineer to assist in maintaining the company's Quality Management System.

Responsibilities Assists in maintaining the company’s Quality Management System (QMS) and assists in the review and development of standard operating procedures, which support quality and regulatory compliance to standards, customer requirements and objectives. Supports engineering efforts by participating in design development projects representing quality assurance and the customer. Investigates and assists with nonconformance report (NCR) dispositions and support of active NCR’s until closure. Participates in the corrective / preventative action (CAPA) process, as assigned. Support the Quality Assurance Manager in oversite of the system and meeting objectives around completion and effectiveness. Responsible for the development of tracking and trending systems for quality information including Nonconforming material (NCR’s), Product Returns (RGA’s), customer complaints and calibration. Works to effectively drive to closures these quality information processes. Promotes and executes quality standards, inspection processes, test methodology, quality plans, calibration methods, documents, reports and the eQMS documentation system Assists in process verification and validation, including development of testing methodology. Reviews customer complaints and works with engineering and production to develop root cause corrective action responses, to include tracking and trending. Develops, executes, and analyzes quality reporting measures, reports issues and trends to management Assists in maintaining processes and documentation related to clean room requirements Reviews suppliers’ corrective actions and non-conformances and establish supplier quality requirements and performance reporting Assists in the development, training, and execution of internal audits; participates as an active member of the audit team Conducts or participates in supplier quality audit process Interfaces with supplier and customer quality representatives concerning nonconformance with products or processes and assure that effective corrective action is implemented. ·May compile, write, and deliver training material on quality system requirements Acts as backup to the Quality Assurance Manager or Quality Control Supervisor in their absence, as defined in the Quality Manual.

Qualifications Bachelor of Science degree in Chemical, Biomedical, Mechanical or Industrial Engineering / Technology or related field A minimum of 1-3 years proven experience in quality engineering, quality control or regulatory affairs Strong understanding of a Quality Management System, such as ISO 13485 or ISO 9001 External auditing experience is strongly preferred Good knowledge of MS Office and databases Great attention to detail and a results driven approach

The Metrix Company offers an excellent compensation and benefits package, including health, dental, optical, life, and disability insurance, as well as a 401k and Profit Sharing Plan.

Candidates must be authorized to work in the United States. Employer will not sponsor applicants for work visas.

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