Quality Control Technician I
GLOBALMED HOLDINGS LLC, Scottsdale, AZ, United States
Job Summary
The Quality Control Technician I performs physical, visual, functional evaluations of incoming materials, in-process sub-assemblies, and finished goods in a highly regulated (FDA/ISO) medical device environment. This involves generating inspection data, recording inspection results, maintaining accurate logs, and drafting detailed reports to ensure products and processes meet industry regulations and company guidelines. This role also engages in the nonconformance process to document, segregate, and disposition any nonconforming materials when inspection requirements are not met, performs customer complaint investigations, contributes to various projects as assigned, and collaborates with other operations personnel to ensure any problems observed are addressed with effective problem solving to minimize future recurrence. This role requires strong attention to detail, proficiency in reading technical drawings, and experience with inspection tools.
Responsibilities
Performs QC inspections using industry-appropriate tools and methods.
Interprets engineering drawings into specifications to establish criteria for inspection.
Documents results by completing inspection records before final review/approval.
Maintains calibrated equipment and helps coordinate the overall calibration program.
Performs other project related duties as assigned.
Qualifications
Associate degree (AA) or equivalent or 1 to 2 years related experience and/or training, or equivalent combination of education and experience.
Familiar with FDA/ISO regulations & guidelines for medical device industry.
Proficient with use and maintenance of mechanical, calibrated inspection tooling.
Familiar with Geometric Dimensioning & Tolerancing (GD&T) in order to read engineering drawings and interpret dimensional & tolerance requirements.
Sufficient knowledge of 5S to maintain standardized workflows & workspace.
Sufficient knowledge of Six Sigma to contribute to process improvement projects.
Proficient with Microsoft Suite (Word, Excel, PowerPoint, SharePoint) and NetSuite.
Able to learn quickly, follow instructions, and complete tasks with minimum supervision.
Treats colleagues with respect and consideration, regardless of the situation.
Applies feedback to improve the quality of product and workflows.
Balances and coordinates team projects and individual responsibilities.
Able to deal with change, delays, or unexpected events.
Experience with technical writing is preferred.
Physical Demands & Work Environment
Ability to work at least 40 hours per week.
Ability to utilize keyboard, mouse, and computer for up to 7 hours per day.
Ability to utilize telephone for approximately 10 minutes per day.
Ability to lift and/or move at least 50 pounds.
Frequently remain in a stationary position throughout the day.
Frequently move around inside and outside the premises.
GlobalMed is an Equal Employment Opportunity Employer.
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The Quality Control Technician I performs physical, visual, functional evaluations of incoming materials, in-process sub-assemblies, and finished goods in a highly regulated (FDA/ISO) medical device environment. This involves generating inspection data, recording inspection results, maintaining accurate logs, and drafting detailed reports to ensure products and processes meet industry regulations and company guidelines. This role also engages in the nonconformance process to document, segregate, and disposition any nonconforming materials when inspection requirements are not met, performs customer complaint investigations, contributes to various projects as assigned, and collaborates with other operations personnel to ensure any problems observed are addressed with effective problem solving to minimize future recurrence. This role requires strong attention to detail, proficiency in reading technical drawings, and experience with inspection tools.
Responsibilities
Performs QC inspections using industry-appropriate tools and methods.
Interprets engineering drawings into specifications to establish criteria for inspection.
Documents results by completing inspection records before final review/approval.
Maintains calibrated equipment and helps coordinate the overall calibration program.
Performs other project related duties as assigned.
Qualifications
Associate degree (AA) or equivalent or 1 to 2 years related experience and/or training, or equivalent combination of education and experience.
Familiar with FDA/ISO regulations & guidelines for medical device industry.
Proficient with use and maintenance of mechanical, calibrated inspection tooling.
Familiar with Geometric Dimensioning & Tolerancing (GD&T) in order to read engineering drawings and interpret dimensional & tolerance requirements.
Sufficient knowledge of 5S to maintain standardized workflows & workspace.
Sufficient knowledge of Six Sigma to contribute to process improvement projects.
Proficient with Microsoft Suite (Word, Excel, PowerPoint, SharePoint) and NetSuite.
Able to learn quickly, follow instructions, and complete tasks with minimum supervision.
Treats colleagues with respect and consideration, regardless of the situation.
Applies feedback to improve the quality of product and workflows.
Balances and coordinates team projects and individual responsibilities.
Able to deal with change, delays, or unexpected events.
Experience with technical writing is preferred.
Physical Demands & Work Environment
Ability to work at least 40 hours per week.
Ability to utilize keyboard, mouse, and computer for up to 7 hours per day.
Ability to utilize telephone for approximately 10 minutes per day.
Ability to lift and/or move at least 50 pounds.
Frequently remain in a stationary position throughout the day.
Frequently move around inside and outside the premises.
GlobalMed is an Equal Employment Opportunity Employer.
#J-18808-Ljbffr