Quality Control Tech I, D shift, 6:00p-6:30a

Terumo Medical Corp

Elkton, MD

JOB DETAILS
SALARY
$36,320–$49,940 Per Year
SKILLS
Algebra, Capability Maturity Model (CMM), Clinical Outcomes, Communication Skills, Computer Skills, Computer Systems, Consulting, Documentation, Environmental Health, Functional Testing, Geography, Healthcare, Healthcare Quality, High School Diploma, Maintain Compliance, Manufacturing, Manufacturing Requirements, Mathematics, Mechanical Testing, Medical Equipment, Medical Products, Organizational Skills, Patient Safety, Presentation/Verbal Skills, Problem Solving Skills, Product Safety, Product Testing, Quality Assurance Methodology, Quality Control, Quality Engineering, Quality System Requirements (QSR), Quality of Life, Regulations, Reporting Skills, Safety Systems, Safety/Work Safety, Sales, Standard Operating Procedures (SOP), Statistical Sampling, Test Equipment, Testing, Traceability, Training Program, Vision Comparator, Writing Skills
LOCATION
Elkton, MD
POSTED
30+ days ago

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

The Quality Control Technician I position is responsible for inspecting, testing, and documentation of in-process and finished products, materials, or components and works within the Quality organization. This position will ensure compliance with Terumo Medical Corporation quality system and interface with production manufacturing, quality, engineering, and others. Consults with Supervisor when questions/problems arise.

Job Details/Responsibilities

  • Associate is responsible to follow requirements of TMC Quality Systems and applicable national / international regulations.
  • Perform visual, functional, and dimensional testing using appropriate instruments to ensure specifications are met. Testing performed typically includes: Mechanical testing (Instron), lubricity/durability testing (OakRiver), Dimensional testing (CMM, Digital measuring microscopes, Keyence, laser micrometer, calipers, micrometers, dial indicators, pin gauges, rulers, protractors), leak testing (Uson, Pressure gauges), etc.
  • Inspect lot numbers, expiration dates, product code numbers, labels, stamps, etc., are in compliance with manufacturing orders and specifications.
  • Use computer systems to maintain traceability and documentation of inspection results.
  • Initiates NC reports and works with management and quality to complete as required.
  • Maintain a safe, clean, and organized work area.
  • May support testing or process execution of test method validations, Engineering protocols, and Quality investigations.
  • Supports rework activities, assists with protocols and the execution and testing of products.
  • Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
  • Performs other job-related duties as assigned.

Knowledge, Skills and Abilities (KSA)

  • Ability to use testing equipment (i.e. calipers, micrometers, microscope, optical comparator, Instron, Laser Mic, Lubricity Tester, etc.).
  • Requires use of Good Documentation Practices (GDP)
  • Effective verbal and written communication skills.
  • Ability to notice trends and differences in raw data.
  • Requires a logical thought process and decision-making ability to make test acceptability decisions based upon quality criteria, engineering criteria, testing results, and product requirements.
  • General computer skills
  • Mathematical knowledge and aptitude including algebra and utilization of sampling plans/statistical charts.
  • Ability to follow written test methods, protocols, and SOP's.
  • Requires the ability to solve basic problems and recommend solutions.

Qualifications/ Background Experiences

  • Requires a high school diploma.
  • Previous experience in Quality Assurance, Quality Control, Manufacturing, Engineering, or Laboratory test support is preferred.

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay: $36,320 - $49,940 plus 15% shift differential.

About the Company

T

Terumo Medical Corp

Today, Terumo Medical Corporation develops, manufactures, exports, imports, markets, distributes, and sells a diverse portfolio of medical devices, supplies, and accessories and generates $280 million in annual sales. While some of our products and devices are produced in Japan, a growing portion of them are produced in Elkton, Maryland, including Pinnacle® Destination® guiding sheaths, Pinnacle® R/0 II sheaths, Terumo® insulin syringes, and CAPIJECT® micro-collection tubes. The manufacturing facility in Elkton spans over 321,000 square feet and utilizes automated processes with a quality system that is certified to be in compliance with the ISO 13485 Standard.

Terumo Medical Corporation offers its wide range of products through three business divisions: Terumo Interventional Systems, Terumo Medical Products, and Terumo Transfusion Products.

  • 1972: Terumo Medical Corporation is founded under the name Kimble Terumo, Inc.
  • 1980: The sales and distribution facility in Piscataway, New Jersey, opens; purchased Owens-Illinois Joint Venture Holdings (Elkton, MD) and name changed to Terumo Medical Corporation
  • 1982: Opening of new Terumo Medical Corporation research and development facility in Elkton, Maryland
  • 1983: CAPIJECT® capillary blood collection tubes are designed, patented, and go on sale in the U.S.
  • 1985: U.S. production of insulin syringes begins
  • 1988: Completion of major manufacturing expansion in Elkton, Maryland
  • 1990: New sales and marketing headquarter office opens in Somerset, New Jersey
  • 1995: U.S. production of cardiovascular devices begins
  • 1999: Sarns division of 3M is acquired and it becomes Terumo Cardiovascular Systems Corporation, a wholly-owned subsidiary of Terumo Medical Corporation
  • 2005: Mission Medical is acquired
  • 2006: MicroVention is acquired; Terumo Interventional Systems begins direct sales of its entire endovascular product line
  • Present: Produces a diverse portfolio of medical devices, supplies, and accessories


  • COMPANY SIZE
    10,000 employees or more
    INDUSTRY
    Medical Devices and Supplies
    EMPLOYEE BENEFITS
    401K, Tuition Reimbursement
    FOUNDED
    1972
    WEBSITE
    http://www.terumomedical.com/