Some opportunities come along once in a career and when they do, you have to act. Our client is a med device start-up involved in a novel technology that addresses an unmet clinical need and it is a group of people who have successfully introduced other new product concepts to the market through start-ups. They have just received clearance on their 510(k) and need to move quickly.
Your core skills need to include Quality and Manufacturing because this person will be hands-on, directing Test Method Validation, IQ/OQ/PQ, and Verification efforts including but not limited to Quality Plans, inspection methods and testing protocols. Your customers will be internal, involving equipment validations, etc. and external where you will be directly involved with vendors.
You will work cross-functionally to ensure documentation is compliant to the needs of ISO 13485, 21 CFR 820, and FDA regulations; participating in Risk Analysis, Data Collection/Analysis, Controls & Procedures. Still interested? Read on.
- Works closely with product development and operations teams (both internally and at suppliers) to prepare and implement quality plans concurrent to FDA and Internationally regulated standards
- Through Test Method Validation and from foundational knowledge in inspection and manufacturing, develops and initiates methods for inspection, testing, and evaluation
- Devises Sampling Procedures/Plans, uses Data collected from internal/external sources to create sampling procedures, develop recording forms, and report results/trends
- Performs hands-on inspection of First Articles, incoming, in-process and final
- Working with operations, coordinates and supports validation activities
- Manages the calibration system to ensure the accuracy of results from analytical equipment, visual and measuring instruments and verifies during supplier auditing, vendor maintenance of their systems
- Provides for disposition of discrepant material including rework and data trends
- Interacts with vendors as a Supplier Quality Representative, ensuring their performance results and methods meet the needs of the Company’s product
- Plans and participates in Supplier audits
- Bachelor’s degree in Engineering, ChE preferred, with a minimum of 5 years’ experience
- Experience with Med Device manufacturing with 3 years of clean room manufacturing preferred
- Well versed in the concepts and principles of inspection techniques and methods
- Demonstrable experience with V&V as well as IQ/OQ/PQ implementation
- Experience in the use and application of GD&T
- Able to interpret engineering drawings and effectively communicate concerns as regards their manufacturability
- Skilled in Data Analysis and Reporting
- Well-informed in FDA 21CFR820 & ISO 13485:2016
- Is a champion for Quality and building a Culture of Quality