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BD (Becton, Dickinson and Company) Quality Engineer I - PMS in Covington, Georgia

Job Description Summary

Job Description

The Quality Engineer, Post-Market Program is primarily responsible for executing and coordinating the day-to-day operations of the post-market surveillance program and related processes.

Additionally, this position executes various quality engineering tasks in support of Quality Assurance and Design Control. The successful candidate will work with teams in Quality, R&D and manufacturing to complete projects while growing expertise and gaining knowledge of products and processes within the business. All work product will follow FDA Quality System Regulations, other FDA regulations, ISO regulations, MDR regulations and international regulations that apply to the products manufactured by BD Urology & Critical Care (UCC).

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

  • Ensures post-market surveillance (PMS) activities are completed on time and in compliance with applicable regulations and company procedures.

  • Responsible for maintaining the PMS procedures, accurate documentation and records, as well as data integrity according to internal requirements.

  • Executes changes to the PMS process, as required, after sufficient collaboration with appropriate individuals.

  • Coordinates with R&D, Clinical Affairs, Medical Affairs, Regulatory Affairs, Marketing, Manufacturing, and Quality to facilitate completion of the PMS Review process and builds productive cross-functional working relationships.

  • Demonstrated ability to use common tools such as Word, Excel, PowerPoint, and various databases.

  • Ability to discern when issues are to be escalated to manager for resolution.

  • Ensures compliance to Business Unit, Segment and Corporate procedures as well as external laws and regulations.

  • Participates in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the business in an efficient, timely, and accurate manner.

  • Travel is less than 10% as required to facilitate completion of duties and responsibilities.

QUALIFICATIONS
  • Strong listening, assessment, questioning, analytical, and problem-solving skills.

  • Ability to manage multiple assignments and projects concurrently.

  • Ability to perform detailed engineering work under the direction of a Senior Engineer and Management.

  • Ability to participate in a team environment and exercise influence management.

  • Basic knowledge and understanding of FDA regulations, ISO standards, EU MDR and other industry standards for medical devices.

  • Good knowledge of statistical techniques and Fundamentals of Engineering Principles.

  • Supports a strong culture of accountability.

  • Basic understanding of Design Control requirements and Risk Management as applied to medical devices.

  • Strong interpersonal skills required in areas of verbal/written communications, customer focus, and professionalism.

Matrix Environment :

This position is required to partner and lead across nearly all functions within the Business Unit without direct reporting structures into those departments. Influence and the ability to clearly define the business and compliance requirements are key to the success of the individual.

EDUCATION/EXPERIENCE

  • B.S. in Engineering, Science, or Technical field, a minimum.

  • Entry-level position, experience with an FDA regulated industry preferred.

PHYSICAL REQUIREMENTS

This position is in an office environment and requires the incumbent to sit for extended periods of time, stand and perform general office functions. The incumbent may also be required to lift up to twenty-five pounds occasionally. Ability to travel as needed.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Office environment

  • Manufacturing environments

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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Primary Work LocationUSA GA - Covington BMD

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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