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. Provide work direction for 1-3 Technicians/Inspectors.
1. Adheres to Integer 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. As required, provide support for customer audits, regulatory audits and inspections, investigations, and inquiries regarding the control and assessment of product design/validation and manufacturing quality.
3. Monitor manufacturing of assigned products, assuring compliance with DMR and assuring complete and correct Device History Records are maintained.
4. Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
5. Lead generation and completion of protocols and reports for validation activity, as required.
6. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
7. 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.
8. Ensure that the disposition of non-conforming materials meet all necessary requirements and assure adequacy of corrective actions to prevent re-occurrence.
9. Lead and manage complaint investigations.
10. Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
11. Participate in continuous improvement projects.
12. Assist with product transfers.
13. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.
14. Mentor and support quality inspectors and technicians.
15. Performs other functions as required.
Bachelor's Degree in Engineering, Business, or related field preferred.
2-5 years quality engineering experience, preferably in medical device or regulated manufacturing
Competence in the selection and use of Quality Engineering Tools and Techniques. Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, etc.).
Proficient in Microsoft Office and Minitab.
Ability to work independently and in team environment.
Ability to effectively communicate written and verbally.
Ability to manage time effectively to ensure timely completion of tasks.
Knowledge of ISO 13485 and/or ISO 9001
Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.