Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7 years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Summary: Ability to inspect incoming raw materials pertaining to Disposables and Electronics, in-process and finished products. 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.
• Perform and review visual, dimensional and functional inspection of incoming raw materials pertaining to Disposables and Electronics. 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 of IQC, In-process, Finals and Electronics as needed.
• 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.
Why Join Us:
• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7 years
• 401k with employee matching available
• Paid vacation, health/dental/vision, and other excellent benefits
An Equal Opportunity Employer