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Terumo Medical Corporation Quality Engineer II in Elkton, Maryland

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 $5+ billion in sales, 20,000+ 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:

This position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently. Ensure compliance to Terumo’s quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

Job Details:

Proactively investigates, identifies, and implements best-in-class. Quality Engineering practices.

Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.

Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Review and approve product and process qualification and validation and other change control related documentation.

Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities.

Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.

Must comply with requirements of applicable national and international regulations

Performs analytical measurements and experiments to qualify or resolve product and process issues.

Will be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.

Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.

Monitor field quality and analyze field returns to determine root cause.

Provide training and support for quality system processes and quality engineering practices.

Perform other job related duties.

Knowledge, Skills, and Abilities

  • Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC

  • Prefer one year of auditor experience.

  • Communication skills both verbal and written.

  • Organizational skills as well as time management skills essential for project work.

  • Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.

  • Excellent computer skills

  • Strong writing, mathematics and statistics skills

Background and Experiences

  • Requires a minimum of a 4 year degree in engineering, life sciences, or similar.

  • Requires three to six years experience in a medical device quality assurance environment.

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.

Job Category: Quality

Affirmative Action/Equal Employment Opportunity Statement

It is the Company'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. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.

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