Quality Control Inspector Medical Devices Jobs (NOW HIRING)

Position Summary:

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.

Essential Functions and Duties:

This position is responsible for performing incoming inspection, quality control in process production, final inspection, and not limited to the following:

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;
Quality 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.

Work Environment/Physical Attributes

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).

The noise level in the work environment is consistently moderate

The employee will work in a fast-paced, team-oriented environment

Standing for long periods and occasional lifting of up to 35 lbs.

Minimum Qualifications:

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.

Preferred Qualifications:

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type:Full Time

Alternative Locations:United States : Mansfield (TX)

TravelPercentage:0%

Requisition ID: 21417