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Quallity System Analyst - Elkton, MD #4551596

Company: Terumo Medical Corporation

Date: 02/14/2018

Category: Medical Devices and Supplies

City: Elkton, MD

Job Summary:

Quality System Analyst will provide direct support in the acquisition, analysis and reporting of Quality System data. This data can come from all facets of the Quality Management organization including: Compliance Department (audit data, external standards management), Manufacturing Quality Operations (NC/CAPA data, production line yield data), Product Surveillance (complaint management and vigilance reporting) and the Training Organization. This role will also support the development of Quality System Management Reviews and the monthly dashboard of Quality System measure (QPI).


• Work with Quality System department heads to identify core measures of system performance

• Establish routine performance measures as required

• Analyze Quality System performance data for the presence of adverse trends and opportunities for continual improvement

• Work with Quality Management functional heads to maintain monthly Quality Performance Index (QPI) dashboard

• Generate standards QPI reports and circulate to executive management

• Support the preparation of Biannual Quality System Management Reviews

• Perform specialized analysis as required in support of investigations, studies etc.

• Other duties as assigned

Qualifications Position Requirements:

Knowledge, Skills and Abilities (KSAs)

  • Knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, CAPA, etc.)

  • Knowledge of medical product manufacturing and development

  • Strong organizational skills as well as time management skills essential for project work

  • Proficient in spreadsheet (report formatting, graphing, formula a calculation generation), database, presentation and project management tools

  • Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, Canadian Medical Device Regulations, ISO 13485, and MDD 93/42/EEC is desirable

Background Experience

  • Requires a minimum of a 4-year degree in engineering, life sciences, business or a combination of prior work experience, education or combination thereof.

  • Minimum of three years of related experience in quality management or engineering

  • Demonstrated ability to interact with all levels of managements, co-workers, and regulators

  • Demonstrated ability with data analysis and report generation using a variety of methods

  • Must possess strong prioritization skills

  • Must possess strong written, verbal, and interpersonal communication skills

  • Strong organizational and presentation skills

Title Quallity System Analyst

Auto req ID 5320BR

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

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