The primary purpose of this job is to provide 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 position may provide work direction for 3-5 Engineers / Technicians / Inspectors.
1. Adheres to GB 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. Ability to interpret drawings, product/performance specifications, and other systems integration technical data
4. Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
5. Leads product and process improvement initiatives.
6. Implements various product and process improvement methodologies
7. Reviews the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
8. Leads in the development, completion, and maintenance of risk analyses.
9. Leads generation and completion of protocols and reports for product, process, and test method validations.
10. 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.
11. As needed, aid in the development of 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.
12. Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
13. Leads and manage complaint investigations and remediation recommendations as needed.
14. Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
15. Assists with product transfers.
16. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
17. Provides technical support to and work direction other Quality Engineers as needed.
18. Performs other functions as required.
Minimum Education: Bachelor's Degree in Engineering, Mathematics or Statistics preferred. Master's Degree preferred.
Minimum Experience: 7+ years' experience in medical device or regulated manufacturing
Specialized Knowledge: 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, CFR, GxP, UL, MDD, TGA etc.) Proficient in Microsoft Office. Thorough knowledge and understanding of manufacturing quality requirements and solutions to obstacles that may impact successful transition at the component, subassembly, and final assembly levels
Ability to work independently with minimal work direction and in a cross-functional 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.
Knowledge of ISO 13485 or 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.