Description SUMMARY OF POSITION:

Leads the Quality Engineering function within new product development including: design for Six Sigma, reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a project team environment. Evaluate component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations. Identifies, qualifies, and implements inspection and test methods. Ensures that components and finished devices are properly specified and inspected, and the associated quality aspects of manufacturing processes are properly designed, analyzed, and validated. Performs failure analysis to prevent or correct component and product failures.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Contributes as a member of product development teams representing the QE function throughout the Product Development Process.

2. Develops/Identifies/Performs:
-Quality Plans
- Risk Management Plans
- Risk Assessments including Hazard Analyses, Risk Analyses, and FMEA’s
- Post Market Surveillance
- QFD’s/CTQ’s
- Measurement Systems Analysis
- Risk based sampling plans
- Inspection and test methods
- Design Verification and Validation strategies
- Acceptance criteria
- First Article Inspection’s and Reports
- Process Capability Analyses
- Inspection/test procedures for production-level components and finished devices

3. Conducts supplier quality system audits as necessary and maintains relationships with vendors.

4. Collaborates/leads the mfg. plant Quality Engineering projects that are part of the development projects, ensuring key quality deliverables have been met.

5. Contributes to the successful completion of Process Validation initiatives:
- Write Validation Master Plans and facilitate the qualification activities required to meet validation requirements.
- Participate in the preparation of IQ, OQ, and PQ protocols, and write summary reports.
- Perform statistical analysis of process data; interpret, compile and organize results.

7. Identifies and implements best practices.

8. Ensures that all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures.
Requirements REQUIRMENTS:

- Requires a B.S. degree in Engineering or associated scientific discipline
- 5-7 years medical devices experience in design, manufacturing, or quality engineering position.
- Proficient in developing and manufacturing medical devices in conformance with Quality System Regulation, ISO 13485, and other regulatory standards.
- Strong understanding of industry expectations in the areas of VOC, Design Verification and Validation, stability studies, sterilization validation, biocompatibility, and transportation testing.
- Strong familiarity with various gages and inspection techniques.
- Ability to interpret mechanical drawings.
- Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer/software packages related to design, development, and manufacturing.
- Knowledge of electro-mechanical devices, IEC 60601, software validation methods, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding) is preferred.
- DFSS or DMAIC certified, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) a plus.
Function Quality Division Med Dev - Patient Care & Safety Products