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 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. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
3. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance 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 test method validations.
6. 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.
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 regulatory 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. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
14. Mentor and support quality inspectors and technicians.
Minimum Education: Bachelor's Degree in Engineering or related field required.
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.
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.
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.