Quality Engineer Technician II
Becton Dickinson, Glens Falls, NY, United States
Quality Assurance Inspector
This role shall support Quality Assurance Inspection and/or Laboratory activities through inspection and verification of manufactured product, materials, and documentation associated with the manufacture of medical devices at this facility. In addition, this position shall support the Non-Conforming Product, Supplier Controls, and Validation Programs by performing such activities as investigating and processing MRRs, placing product on Quality Hold, managing rework, trending data, and creating and processing Change Requests.
Job Functions:
Verify completeness and accuracy of Device History Records and test data following appropriate procedures through all process steps and inspections.
Collect, document and maintain accurate manual and computerized records.
Assist in writing test and inspection procedures.
Initiate documents following appropriate procedures.
Reviews test results of analytical and sterilization results against Specifications.
Assist with Change Requests (CRs) that improve Specification clarity and procedure improvements.
Perform Lot release inspections
Perform incoming component inspections
Build rework instructions
Organize product holds and releases
Depending on assignment, may work with vendors on Supplier Corrective Action Requests.
Track and trend quality data
Inspect product and raw materials to specified parameters using sampling plans in accordance with detailed procedures.
Set up and operate a wide range of test equipment for (a) Physical Test Lab, i.e. tensile testing, thickness, density, and optical comparison, etc.
Perform other related duties as assigned.
Basic Qualifications:
Strong track record of performance, especially in Quality.
Must have strong time planning, organization and interpersonal communication skills.
Mechanical proficiency, capable of using measuring equipment and reading product specification drawings.
Strong writing skills and IT systems navigation such as MasterControl, etc.
Validated ability to build EXCEL spreadsheets including use of formulas, charts, etc.
Must be capable of understanding and applying sampling plans.
Must be able to understand laboratory test methods and equipment.
Must be able to demonstrate visual accuracy.
Education and/or Experience:
Four-year degree in science or technical related field of study--or--Two-year degree and three (3) years of experience as a Quality Control Technician or equivalent inspection experience.--or--HS Diploma, GED and a minimum of Five (5) years of experience as a Quality Control Technician or equivalent inspection experience.
Proficiency in reading, writing, and math skills including algebra, statistical math skills up to trigonometry. (Must understand mean and standard deviations).
Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment visa at this time.
Preferred: Previous medical device manufacturing or inspection experience
Physical Demands:
Occasionally requires light physical effort as in periods of prolonged standing, sitting at machines or work tables or bending, stooping or reaching and/or lifting of object from desk to chair weighing 30 lbs, above shoulder weighing 30 lbs, push/pull 64 lbs, chair to floor 50 lbs., carry 50 lbs (2 hands); 25 lbs. one hand.
Must successfully pass Job Physical Ability (JPA) test, conducted by designated outside party at company's expense.
Will require some exposure to chemicals used in manufacturing processes
Work Environment:
Some minor physical inconvenience or discomfort occasionally present in the work situation (moderate noise, disagreeable odors, etc.) OR occasional exposure to minor injury or other health hazard requiring some precaution.
Eligible for Lutonix monitoring program.
Training Requirements:
On-the-Job, SOP's required for position and GMP.
Primary Work Location: USA NY - Glens Falls
Work Shift: US BD 1st Shift 8am-4pm (United States of America)
This role shall support Quality Assurance Inspection and/or Laboratory activities through inspection and verification of manufactured product, materials, and documentation associated with the manufacture of medical devices at this facility. In addition, this position shall support the Non-Conforming Product, Supplier Controls, and Validation Programs by performing such activities as investigating and processing MRRs, placing product on Quality Hold, managing rework, trending data, and creating and processing Change Requests.
Job Functions:
Verify completeness and accuracy of Device History Records and test data following appropriate procedures through all process steps and inspections.
Collect, document and maintain accurate manual and computerized records.
Assist in writing test and inspection procedures.
Initiate documents following appropriate procedures.
Reviews test results of analytical and sterilization results against Specifications.
Assist with Change Requests (CRs) that improve Specification clarity and procedure improvements.
Perform Lot release inspections
Perform incoming component inspections
Build rework instructions
Organize product holds and releases
Depending on assignment, may work with vendors on Supplier Corrective Action Requests.
Track and trend quality data
Inspect product and raw materials to specified parameters using sampling plans in accordance with detailed procedures.
Set up and operate a wide range of test equipment for (a) Physical Test Lab, i.e. tensile testing, thickness, density, and optical comparison, etc.
Perform other related duties as assigned.
Basic Qualifications:
Strong track record of performance, especially in Quality.
Must have strong time planning, organization and interpersonal communication skills.
Mechanical proficiency, capable of using measuring equipment and reading product specification drawings.
Strong writing skills and IT systems navigation such as MasterControl, etc.
Validated ability to build EXCEL spreadsheets including use of formulas, charts, etc.
Must be capable of understanding and applying sampling plans.
Must be able to understand laboratory test methods and equipment.
Must be able to demonstrate visual accuracy.
Education and/or Experience:
Four-year degree in science or technical related field of study--or--Two-year degree and three (3) years of experience as a Quality Control Technician or equivalent inspection experience.--or--HS Diploma, GED and a minimum of Five (5) years of experience as a Quality Control Technician or equivalent inspection experience.
Proficiency in reading, writing, and math skills including algebra, statistical math skills up to trigonometry. (Must understand mean and standard deviations).
Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment visa at this time.
Preferred: Previous medical device manufacturing or inspection experience
Physical Demands:
Occasionally requires light physical effort as in periods of prolonged standing, sitting at machines or work tables or bending, stooping or reaching and/or lifting of object from desk to chair weighing 30 lbs, above shoulder weighing 30 lbs, push/pull 64 lbs, chair to floor 50 lbs., carry 50 lbs (2 hands); 25 lbs. one hand.
Must successfully pass Job Physical Ability (JPA) test, conducted by designated outside party at company's expense.
Will require some exposure to chemicals used in manufacturing processes
Work Environment:
Some minor physical inconvenience or discomfort occasionally present in the work situation (moderate noise, disagreeable odors, etc.) OR occasional exposure to minor injury or other health hazard requiring some precaution.
Eligible for Lutonix monitoring program.
Training Requirements:
On-the-Job, SOP's required for position and GMP.
Primary Work Location: USA NY - Glens Falls
Work Shift: US BD 1st Shift 8am-4pm (United States of America)