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Quality Control Inspection Technician

System One
Leesburg, VA
  • Expired: September 23, 2022. Applications are no longer accepted.

Title: Quality Control Inspection Technician

Location: Leesburg, VA

Start date: ASAP

Responsibilities:

+ High School diploma or equivalent. Prefer vocational/technical school training. Prefer formal GD&T training (Geometric Dimensioning and Tolerancing).

+ Must have 3+ years of product inspection experience in a cGMP manufacturing environment.

+ Prefer experience with inspection of hand finishing, buffing, laser-marking, masking or blasting processes for implants, instruments or other production parts

+ Demonstrated ability to read blueprints

+ Demonstrated proficiency in the use of all standard inspection tools including calipers, micrometers, height gages and comparators

+ Demonstrated understanding of Inspection Sampling Plans

+ Demonstrated familiarity with GD&T

+ Demonstrated computer skills including basic proficiency in MS Outlook and intermediate proficiency in MS Word and Excel

+ Must be able to lift up to 25 pounds on an occasional basis

+ Must be willing and able to work weekday, weekend and mandatory overtime hours as required to meet the production demands of the team; Demonstrated ability to train others

+ Demonstrated communication and interpersonal skills and the ability to work in a team-based environment that heavily emphasized quality, performance, cross-training, customer service and accountability

+ Demonstrated understanding of FDA CFR 820 and EN 13485 Regulations; Demonstrated experience in performing incoming receiving inspection

+ Prefer demonstrated understanding of packaging or clean line process and assembly for implants, instruments, or production parts.

+ Ability to read complex mechanical blueprints.

+ Working knowledge of GMP compliance for Class II Medical Devices preferred.

+ Must be able to accurately document and maintain records.

+ Basic knowledge using measurement equipment such as calipers, micrometers, optical comparator, video measurement equipment, plug gauges, etc. preferred.

+ Proficient English written and verbal communication skills required.

+ Must have good computer skills and experience with database, spreadsheet, and word processing software (MS Access, MS Excel, MS Word required).

+ Basic understanding of machining processes.

+ Knowledge of ISO 13485 preferred.

+ While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.

+ Frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear.

+ Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Requirements:

+ Perform quality assurance and quality control inspection duties, including inspection of implants, instruments and gauges as required to ensure the dimensional and visual integrity of product in accordance with all required quality specifications, standards, goals and objectives.

+ Perform receiving inspection and related activities.

+ Perform dimensional and visual inspection to blueprint using standard gages, custom gages and comparators

+ Read and inspect to blueprints and/or inspection guide sheets

+ Perform Document Review and Product Verification Inspection (PVI) in compliance to GMP requirements

+ Perform material and component Receiving Inspections; Inspect, calibrate and qualify gages; Verify First Article Inspection (FAI) data

+ Perform Oracle system transactions related to Router Inspections

+ Segregate, quarantine and complete documentation for non-conforming materials when necessary.

+ This position ensures that all purchased, in-process, and completed product is manufactured within specifications regarding configuration, dimension, aesthetics, contamination, surface finish, packaging/ labeling, and material properties to meet the company's quality and GMP requirements.

+ Under supervision, performs visual, dimensional, and functional inspections of raw material, components, in-process, and final product based on documented specifications (i.e. drawings, procedures, work instructions, etc.) with a high degree of accuracy.

+ Record inspections by entering them into the computerized quality database.

+ Transacts parts in inventory control system (JD Edwards).

+ Initiates nonconformance reports to prescribed procedures.

+ Effectively supports and follows policies and procedures.

+ Other duties as assigned or apparent.

System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

System One

Address

Leesburg, VA
20178 USA

Industry

Manufacturing

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