Kelly Services Quality Assurance Technician - 1st Shift in Shirley, Massachusetts
Quality Assurance Technician 1st Shift – Shirley, MA
Kelly Services is currently seeking Quality Assurance Technician – 1st Shift for one of our top clients in Shirley, MA.
JOB TITLE: Quality Assurance Technician – 1st Shift
INDUSTRY: Medical Device
WORK LOCATION: Shirley, MA
DURATION: 12 Months (Temporary / Contract)
HOURS: 1st Shift 8:00 AM - 5:00 PM Monday, Tuesday, Wednesday, Thursday, Friday
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. Perform incoming and or in- process inspections according to internal policies and procedures.
Essential Duties & Responsibilities:
• Perform required inspections, measurements and testing of incoming parts, in-process assemblies, and finished products per established criteria; record results on appropriate documentation; and communicate any discrepancies to the person(s) responsible for corrective/preventive action activity.
• Perform various dimensional inspections using specific dies, gages, meters, micrometers and other dimensional inspection systems; and indicate inspection status of parts with assigned labels and stamps.
• Record inspections by entering them into the computerized quality database
• Transacts parts in inventory control system (IQMS)
• Verify supplied documentation is complete and accurate including Certificate of Conformance and Material Verifications (incoming)
• Maintain product identification and traceability; help control non-conforming product in accordance with documented procedures; and assist with control of measuring and test equipment calibration.
• Be proficient in the document control system (Arena)
• Identify the need for and design of gauges and/or tooling
• Initiate Nonconforming Material Reports (NCMRs) to prescribed procedures and may be called upon to coordinate the resolution of NCMRs. Interface with other departments to get timely resolution of discrepancies
• Provide leadership to junior QC inspectors and production personnel on quality issues.
• Comply with and reinforce the requirements of the Quality Manual and Standard Operating Procedures, ISO 13485, FDA Quality System Regulations and other customer standards.
• Performs job duties with little or no supervision or assistance.
Education & Special Training: Ability to read complex mechanical blueprints, technical drawings and specifications • Experience with ANSI Y14.5 Geometric Tolerancing • Must be able to accurately document and maintain records • Must be proficient in the use of measurement equipment such as calipers, micrometers, dial and digital indicators, optical comparator, ring gages, pin gages, video measurement equipment, thread gauges, etc. • Understanding of thread specifications and classifications • Basic understanding of machining processes • Experience with C=0 and ANSI Z1.4 Sampling Plans (Previously MIL Std. 105E) • Excellent English written and verbal communication skills required • Excellent math skills required • Basic knowledge of industry regulations and standards, such as FDA, USP, and/or ISO.
Qualifications & Experience: • High school Diploma or GED; some college or technical training preferred. Minimum of 2 years’ experience in a quality inspector capacity preferred or 4-5 years related experience and/or training. • Prior medical device or regulated manufacturing environment experience required. • Proficient in Microsoft Office Suite, an ERP system, and Document Control software system. • Prior experience operating portable CMM equipment and understanding of Geometric dimensioning and tolerancing (GD&T) required • FDA QSR (cGMP) knowledge required, ISO 13485 preferred Physical & Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls. The employee 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.
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire*
Let us help advance your career today.
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
About Kelly ®
At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
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