Montes Medical Group Inc
Sr. Quality Assurance Technician
Montes Medical Group Inc, Hopkins, Minnesota, United States, 55305
* *FIRST SHIFT*
Do you have the right skills and experience for this role Read on to find out, and make your application.
*Purpose and Scope*
This role is responsible for performing routine in-process and final inspection of finished devices as well as raw materials and components inspections. This role will assist in designing and developing new processes, tests methods, and/or control systems, and ensure that all Quality-related job responsibilities are carried out according to established procedures and policies.
*Primary Organization Responsibilities*
· Follows set training program for position and ensures training requirements are up to date.
· Interacts with Manufacturing to support product quality issues.
· Performs start-up, in-process and final product inspections.
· Interprets and understands internal drawings and specifications to inspect received (incoming) materials in accordance with purchase orders and specifications.
· Supports nonconformance investigations, ensuring thorough documentation and timely resolution.
· Measures dimensions of materials/components/product using precision tools such as calipers, gages, microscopes, comparators, etc.
· Measures electrical and optical components/assemblies using power meters, multimeters, PCB inspection tools and jigs.
· Maintains highly accurate and legible quality records and reviews quality records for completeness.
· Makes recommendations on decisions as to the acceptable quality; reasons for rejection; completes required quality records. Identify, initiate quarantine, report and document all non-conforming product.
· Identifies, reports and documents all discrepancies and potential product quality problems. Participates in root cause analysis. Assists QE in non-conforming material/part transactions, management and tracking of non-conformances.
· Develops and execute First Article Inspection reports. Supports Gage R&R, Qualifications and Validations.
· Performs peer review of inspection reports to ensure complete and accurate results have been documented.
· Identify improvement opportunities and implement process changes.
· Demonstrates safe work habits, maintains clean and safe work area.
· May perform other duties as assigned.
*Qualifications*
· High school diploma or equivalent with 5+ years of experience in quality assurance in the medical device or regulated industry; or associate degree in a technical field with 3+ years of experience.
· Experience with inspection techniques (visual, mechanical, dimensional, functional) and measurement tools (calipers, micrometers, CMM, etc.).
· Proficiency in reading and interpreting engineering drawings, specifications, and GD&T.
· Strong documentation and record-keeping skills with attention to detail.
· Effective communication skills and ability to work independently or in a team environment.
· Knowledge of measurement systems (SI, English), perform measurement conversions (scientific, decimals, and fractions).
· Must be proficient in the use of computer software applications, (Microsoft Excel, Word, SPC).
*Preferred Qualifications*
· Experience in drafting technical reports, inspection/test methods, and other quality documents.
· Experience in programming vision, CMM, and other automated test systems is highly preferred.
· Experience inspecting electrical and optical components/assemblies is highly preferred.
· Familiarity with statistical analysis tools (Minitab, JMP, etc.)
· Quality Technician Certification from ASQ.
*Physical Requirements:*
· Ability to sit, stand, or walk for extended periods.
· Manual dexterity for operating testing equipment.
· Occasionally lift up to 35 lbs.
Job Type: Full-time
Pay: $21.00 - $42.00 per hour
Expected hours: 40 per week
Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Health insurance * Health savings account * Life insurance * Paid time off * Vision insurance
Shift availability: * Day Shift (Preferred)
Ability to Commute: * Minnetonka, MN 55305 (Required)
Work Location: In person
Do you have the right skills and experience for this role Read on to find out, and make your application.
*Purpose and Scope*
This role is responsible for performing routine in-process and final inspection of finished devices as well as raw materials and components inspections. This role will assist in designing and developing new processes, tests methods, and/or control systems, and ensure that all Quality-related job responsibilities are carried out according to established procedures and policies.
*Primary Organization Responsibilities*
· Follows set training program for position and ensures training requirements are up to date.
· Interacts with Manufacturing to support product quality issues.
· Performs start-up, in-process and final product inspections.
· Interprets and understands internal drawings and specifications to inspect received (incoming) materials in accordance with purchase orders and specifications.
· Supports nonconformance investigations, ensuring thorough documentation and timely resolution.
· Measures dimensions of materials/components/product using precision tools such as calipers, gages, microscopes, comparators, etc.
· Measures electrical and optical components/assemblies using power meters, multimeters, PCB inspection tools and jigs.
· Maintains highly accurate and legible quality records and reviews quality records for completeness.
· Makes recommendations on decisions as to the acceptable quality; reasons for rejection; completes required quality records. Identify, initiate quarantine, report and document all non-conforming product.
· Identifies, reports and documents all discrepancies and potential product quality problems. Participates in root cause analysis. Assists QE in non-conforming material/part transactions, management and tracking of non-conformances.
· Develops and execute First Article Inspection reports. Supports Gage R&R, Qualifications and Validations.
· Performs peer review of inspection reports to ensure complete and accurate results have been documented.
· Identify improvement opportunities and implement process changes.
· Demonstrates safe work habits, maintains clean and safe work area.
· May perform other duties as assigned.
*Qualifications*
· High school diploma or equivalent with 5+ years of experience in quality assurance in the medical device or regulated industry; or associate degree in a technical field with 3+ years of experience.
· Experience with inspection techniques (visual, mechanical, dimensional, functional) and measurement tools (calipers, micrometers, CMM, etc.).
· Proficiency in reading and interpreting engineering drawings, specifications, and GD&T.
· Strong documentation and record-keeping skills with attention to detail.
· Effective communication skills and ability to work independently or in a team environment.
· Knowledge of measurement systems (SI, English), perform measurement conversions (scientific, decimals, and fractions).
· Must be proficient in the use of computer software applications, (Microsoft Excel, Word, SPC).
*Preferred Qualifications*
· Experience in drafting technical reports, inspection/test methods, and other quality documents.
· Experience in programming vision, CMM, and other automated test systems is highly preferred.
· Experience inspecting electrical and optical components/assemblies is highly preferred.
· Familiarity with statistical analysis tools (Minitab, JMP, etc.)
· Quality Technician Certification from ASQ.
*Physical Requirements:*
· Ability to sit, stand, or walk for extended periods.
· Manual dexterity for operating testing equipment.
· Occasionally lift up to 35 lbs.
Job Type: Full-time
Pay: $21.00 - $42.00 per hour
Expected hours: 40 per week
Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Health insurance * Health savings account * Life insurance * Paid time off * Vision insurance
Shift availability: * Day Shift (Preferred)
Ability to Commute: * Minnetonka, MN 55305 (Required)
Work Location: In person