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 3-5 Technicians/Inspectors.
1. Adheres to Integer Values 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.
Minimum Education: Bachelor's Degree in Engineering or related field required.
Minimum Experience: 5-7 years' experience in medical device or regulated manufacturing
Competence in the selection and use of Quality Engineering Tools and Techniques.
Good knowledge in the interpretation and application of relevant Domestic and
International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA 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 SPC, FMEA, DOE, RCA, GDT
Sound knowledge of quality management systems.
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.