Quality Technician

Brooksource; Minnesota; On-site; USD 45,000 - 65,000; Full time

Job summary

Brooksource in Minnesota is seeking a Quality Technician to support the Design Quality Engineering team. You will review inspection/test data for GDP, perform data entry and calculations, and help maintain GDP and cGMP records.

Strong attention to detail and ability to work with cross-functional teams are essential. You will execute inspections using instruments like calipers, microscopes, laser micrometers, and Instron, generate NCRs, and assist in non-conformance investigations.

Qualifications

• GDP, QMS, and regulatory data-review expectations.
• Familiar with cGMP, QSR, ISO13485 requirements.
• Experience with GDP, GLP, and GMP practices.
• Ability to read technical specs and drawings.
• MS Office proficiency, especially Excel and Word.

Responsibilities

• Review test and inspection data to ensure GDP and data integrity.
• Perform electronic data entry, calculations, and data analysis.
• Initiate Document Change Orders reflecting QMS requirements.
• Inspect/test medical devices using various measurement systems and generate NCRs.
• Perform functional testing per specifications or test protocols.
• Generate detailed inspection/testing reports per cGMP and maintain files.
• Handle non-conforming product and assist in investigations.
• Coordinate calibration activities and maintain equipment logs.
• Support QSR and FDA regulations and company procedures.
• Interface with cross-functional project teams.
• Other duties as assigned.
• May lift objects up to 25 lbs.

Skills

GDP compliance

Data analysis

Documentation

Cross-functional communication

Attention to detail

Education

High school diploma

Associate’s degree

Tools

Instron

Calipers

Microscope

Laser micrometer

Pin gauges

Job description

Job Description

The Quality Technician provides support to the Design Quality Engineering (DQE) team in day-to-day activities. The Quality Technician will need to have experience reviewing inspection/test data for Good Documentation Practices andobservingtesting to ensure compliance with test methods.The Quality Technician should be competent in performing inspections/testing using various measurement systems and recording data.

Responsibilities:

• Review test/ inspection data and ensure data adheres to Data Integrity requirements, including Good Documentation Practices (GDP)
• Perform basic electronic data entry, calculations, and data analysis.
• Initiate Document Change Orders to reflect current QMS requirements, for continuous improvement, or update according to GDP requirements: Data collection forms, Procedures, and Test Methods
• Perform inspection/testing of medical devices components, subassemblies, finished goods, and tools & fixtures using various measurement systems (e.g., visual measurement systems, microscopes, laser micrometer, pin gauges, Instron, calipers, snap/drop gages, balloon burst tester, etc.) and generate NCRs as necessary
• Perform functional testing of components, assemblies, and or finished products following the required specifications or per test protocols
• Generate detailed andaccurateinspection and testing reports according to Current Good Manufacturing Practices (cGMP) andmaintaininspection and testing files as per procedures
• Handle non-conforming product, including movement to/from quarantine locations andappropriate labeling, andassistin non-conformance investigations
• Support equipment program by coordinating calibration activities,maintainingequipment status in electronic system, andmaintainingqualification records / logs
• Support company goals andobjectives, policies, and procedures, QSR, and FDA regulations
• Interface and communicate effectively with cross-functional members of project teams
• Other duties as assigned.

Requirements:

• High school diploma with a minimum of 3 years’ experience in the medical device industry (Quality Assurance preferred). Associate’s degree is a plus
• Understanding of cGMP, QSR and ISO13485 requirements
• Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP)and Good Laboratory Practices (GLP)
• Ability to understand and follow Quality Management System Procedures (e.g., SOP and Test Methods)
• Working experience doing data review per Good Documentation Practices (GDP)
• Working knowledge in reading and interpreting technical specifications and mechanical drawings
• Experience with data analysis and ability to perform basic calculations
• Knowledge of a wide variety of inspection, test equipment, and test methodologies
• Experience performing inspections and testing activitiespertaining toDesign Validation & Verification in the medical device industry, and recording data following GDP
• Excellent visual acuity to perform visual inspections involving small defects, small parts, and/or operation of machines using measurement devices
• Ability to communicate effectively with all cross-functional team members
• Operate as a team and/or independently whiledemonstratingflexibility to changing requirements
• Organized and detail-oriented
• Proficient with MS Office including Excel and Word
• May berequiredto work in a Controlled Environment Room (CER) as needed.
• Effective written and verbal communication skills
• Ability to work in a fast-paced environment while managing multiple priorities
• Experience in a small site environment with developing procedures and variety of responsibilities a plus
• May berequiredto lift objects up to 25lbs

Preferred Experience:

• Experience with catheter products and their components a plus
• Experience working in both R&D and production environments and ability to flex between the requirements of each