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BD (Becton, Dickinson and Company) Quality Systems Specialist I in Louisville, Colorado

Job Description Summary

Job Description

SUMMARY

As directed by the Manager, Quality Systems, the Quality Systems Specialist is accountable for establishing and maintaining quality standards of existing product and services, as well as developing programs to focus employees on continuous improvement.

  • Ensures applicable Quality Systems deliverables comply with current ISO 13485, 21CFR 820 and corporate requirements.

  • Ensures accurate and actionable records for the making of decisions.

  • Ensures R&D processes follow applicable released procedures.

PRIMARY RESPONSIBILITIES AND DUTIES include the following.

  • Responsible for Quality Systems activities as assigned

  • Maintains awareness, follows applicable corporate quality procedures and makes updates to procedures, policies, training matrices and curriculums.

  • The Quality Systems Specialist will be accountable for basic application of Quality Systems principles in the areas of document control, complaint management and other broad quality systems areas.

  • Prepare, create and maintain various types of documents such as quality documents and manufacturing specifications for BD products and services.

  • Assist in the development and evaluation of new processes and procedures.

  • Analyze existing processes and procedures to suggest continual improvements

  • Provide general audit support

  • Participate and represent Quality on projects, implementations and initiatives associated with regional improvement goals, annual quality objectives, integration and optimization as assigned.

  • Other duties and responsibilities as assigned.

  • Performs day-to-day activities under direct supervision

  • Follows specific, detailed instructions

  • Notifies manager upon recognition of factors that may affect project deliverables

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Excellent communication, problem solving, organizational and interpersonal skills

  • Computer skills (Excel, Word, Power Point, etc.)

  • Self-motivated and directed, requiring minimal supervision

  • Demonstrated ability to work in teams to obtain results is required.

  • Effective skills in analytical thinking and problem solving required.

EDUCATION and/or EXPERIENCE

  • Bachelors Degree in Quality Engineering or related Science discipline preferred

  • 0 - 2 years experience

  • Limited knowledge of ISO 13485 regulations preferred.

LANGUAGE SKILLS

Excellent oral and written communication skills in English are required, with abilities in Spanish a desirable additional skill.

MATHEMATICAL SKILLS

Basic mathematical abilities of addition, subtraction, multiplication and division are required. Some ability to apply basic concepts of basic algebra and geometry are desirable.

PHYSICAL DEMANDS

Required to sit, talk, hear, stand, bend, reach with hands, lift or move up to 25 lbs. (archive record boxes). Vision requirements include ability to see and interact with a computer.

WORK ENVIRONMENT

This position works in a normal office environment. The noise level in the work environment is quiet to moderate.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work LocationUSA CO - Louisville

Additional Locations

Work ShiftUS BD 1st Shift 8am-5pm (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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