Quality Engineer
 Aleron | |
 United States, New York, Alden | |
| 11900 Walden Avenue (Show on map) | |
 Nov 04, 2024 | |
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Description A Quality Engineer job in Alden, NY is available through Acara Solutions. The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
This is a contract opportunity that will pay between 35 and 45 an hour.
Job Responsibilities 1. Adheres to Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. 2. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. 3. Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. 4. Leads and implements various product and process improvement methodologies. 5. Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. 6. Leads in the completion and maintenance of risk analysis. 7. Leads generation and completion of protocols and reports for test method validations. 8. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. 9. Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures. 10. Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence. 11. Effectively communicate and interact with customers. 12. Leads and manage complaint investigations. 13. Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. 14. Assists with product transfers. 15. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. 16. Provides support to other quality engineers. 17. Performs other functions as required. Job Requirements Required Skills / Qualifications:
Preferred Skills / Qualifications:
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status. Apply | |