Summary:
Ability to inspect in-process and finished products in the cleanroom environment. Act as coordinator within Quality Operations and ensure needs of internal customers are met. Document all non-conformances when necessary. Assist with investigations pertaining to, both, customer complaints and internal non-conformances. Understand, follow, and practice the rules/regulations set forth by the QSR, ISO 13485, and Quest Medical management.
General Duties and Responsibilities:
- Review processes to assure procedural compliance and recommend improvements
- Provide support during internal, customer and regulatory audits
- Ability to identify key inspection points and the proper tools/equipment to ascertain these points.
- Perform inspections and verification of finished products.
- Perform Line clearance and in-process inspections.
- Review inspection data and DHRs (including sterilization records) for accuracy and compliance to the applicable standard(s).
- Perform inspections and process Returned goods/ materials (RGAs/RMAs).
- Evaluate materials for extending Expiration dates.
- Use recognized sampling plans to determine statistical size of samples
- Perform and review tests according to various protocol requirements
- Document and review inspection results per GMP/GDP.
- Provide/coordinate training for new Technicians.
- Generate non-conforming material reports (NCMR) for products that do not conform to test specifications and contact the appropriate personnel.
- Communicates needs of department/company to management.
- Coordinate needs of internal customers and communicate to technicians in his/her area of responsibility.
- Assist engineering staff with process improvement projects regarding improved quality inspection of product and components (such as First Article Inspections and qualification testing)
- Evaluate certification status of raw materials under the Supplier Certification program.
- Ability to work in Quality Operation areas Cleanroom In-Process QC, Finals QC.
- Ability to work on projects related to new instrumentation.
- Ability to redline documents for improvements or compliance.
- Ability to use pallet jack to move materials.
- Ability to lift materials weighing up to 50lbs.
Qualifications:
- High School graduate or equivalent work-related experiences with some previous quality control experience desired (minimum of 5 years).
- Strong inspection ability using a caliper, micrometer, vision system including optical comparator, OGP Smart system, and other inspection and measurement tools.
- Detail oriented, computer literate and possesses a professional demeanor, be adaptable to changing environments and capable of completing tasks with little or no supervision.
- Computer skills including MS Office (basic knowledge).
- Good written and oral communication skills are required and must be able to read, write, and understand English. Interpersonal skills dealing with other departments/individuals in a team atmosphere important.
- Ability to read and interpret engineering DWGs, product specifications, and procedures and use metrology and other testing equipment.
- Medical device experience desired.
