Quality Control Inspector

Straumann•Mansfield, TX

47d•Onsite

About The Position

The operator is responsible for checking all batches during incoming inspection, in process, and before delivery to outbound any non-conformities according to the product specification and control plan.

Requirements

Completed High School Diploma or equivalent required.
Minimum 3+ years of experience working in quality control processes.
Basic understanding of the manufacturing requirements in regulated environments.
Basic understanding of Good Documentation Practices (GDP)
Able to interact with a computer-managed workflow.
Proficient in computer skills, including Microsoft Outlook, Word, and Basic Excel.

Nice To Haves

Basic knowledge of SAP or ERP system
Basic understanding of medical devices or dental implant products.
Basic knowledge of Machining
Knowledge of Quality Tools, including sampling plan, Measuring Instruments
Basic knowledge of FDA regulation, ISO 13485:2016 requirement, Health Canada and MDD/MDR requirements
Ability to work with small, high-quality parts, critical analysis, and attention to detail.
Able to communicate and collaborate effectively.

Responsibilities

Access SAP system to obtain the material and production information for incoming inspection
Select and evaluate samples of materials, semi-finished products, or products from each batch
Perform required inspections to ensure the material and products conform to the approved specification and control plan in SAP
Disposition the material and product (pass/fail) according to the approved specification and control plan
Records inspection results in SAP system
Perform final disposition batches to distribution.
Review and complete the final Device History Records according to Good Documentation Practices
Handling the non-conforming material, product, as per the approved work instructions
Participate, when necessary, in quality, production, process or development activities
Keep the information and documents of the processes updated, controlled and archived, through electronic or physical means, when applicable.
Provide technical advice to its internal clients on matters in its area of expertise.
Keep up to date with the concepts, techniques, tools, methodologies and trends of the subjects related to their area of expertise.
Analyze problems that have occurred, proposing and implementing solutions that ensure the continuity of the work.
Support the development of various reports, aiming to support technical and managerial decision-making.
Record the tasks performed, including time notes, in the software adopted by the company.
Propose improvements in processes.
Analyze proposals and develop process improvements
Implement procedures, methodologies, standards and policies, as well as solutions for matters related to its area of operation
Comply with all medical device regulation requirements, internal and general, and human resources policies of Straumann Manufacturing, Inc.
Other duties as assigned by the management.
Comply with and maintain the commitment to the Quality Policy
Adherent to all company policies, work rules, and the Straumann Code of Conduct, including Ethics.
Ensure the environmental conditions at the workstation are in accordance with the definitions and requirements for organization, cleaning, equipment, and operating instructions.
Follow procedures and complete documentation
Perform job duties in compliance with work instructions.
Apply a disciplined approach to ensuring conformance to medical device regulations, and clean and maintain production equipment standards.
Maintain a clean and safe work area.
Comply with the Medical Devices Good Manufacturing Practices
Ensures safety of manufacturing processes to protect employees from work-related harm (zero-accident mentality).