Quality Control Tech I, 2nd Shift

Terumo Cardiovascular Group; Elkton (MD); On-site; USD 42,000 - 65,000; Full time

Job summary

Terumo Medical Corporation is seeking a Quality Control Technician I to inspect, test, and document in-process and finished products, materials, or components. The role interfaces with production, quality, and engineering to ensure adherence to the quality system.

The ideal candidate will follow GDP and SOPs, perform mechanical and dimensional testing with instruments like Calipers, Micrometers, CMM, and Instron, and maintain accurate documentation and traceability across manufacturing

Qualifications

• Requires a high school diploma and basic quality control knowledge.
• Experience in Quality Assurance, Quality Control, Manufacturing, Engineering, or Laboratory support is preferred.
• Must follow GDP and SOPs; promote accurate documentation and traceability.

Responsibilities

• Inspect in-process and finished products, materials, or components for conformance.
• Perform visual, functional, and dimensional testing using specified instruments.
• Maintain traceability and document inspection results in computer systems.
• Initiate NC reports and coordinate with quality and management to resolve issues.
• Maintain a clean, safe, and organized work area.
• Support testing or process validation activities and quality investigations.

Skills

Testing equipment

GDP

Communication

Data analysis

Decision making

Math

SOPs

Problem solving

Education

High school diploma

Tools

Calipers

Micrometers

CMM

Instron

Laser micrometer

Job description

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Department: Quality Control Manufacturing

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.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

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.

• 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.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

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.
• 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.