Job Description Summary

This position is responsible for working in the Bard Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. Quality results are expected to ensure the integrity of Bard complaint investigations. Additionally, the Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

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

• Creates investigation files in the BARD Global complaint system (Trackwise).

• Performs complaint investigations for all BMD and OEM manufactured products.

• Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.

• Provides support to Project Teams and Quality Department.

• Creates, reviews and approves Quality System Documents (SOP, CAPA, Audits, SPAs and R002s)

• Sets up, safely operates, and maintains laboratory equipment and testing instruments.

• Responsible for all products testing in the Complaint Laboratory in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

• Develops and maintains a working knowledge of BMD policies and procedures and ISO and FDA requirements and ensures compliance to Department and Division procedures.

• Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis. May present data findings to peers, engineering and management staff.

• Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Bard policies

• Performs tasks accurately and with great attention to detail.

• Technical competence in testing and writing and responsible for timely notifications based on new information received to FA specialists to meet FDA reporting requirements.

• Represents the Corporation, Division and Quality Department in a professional manner.

QUALIFICATIONS

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

• Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.

• Basic knowledge of medical device regulation, industry or international standard.

• Broad knowledge of Medical Device complaint reporting requirements.

• Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment.

• Understanding of laboratory instrumentation.

• Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory.

• Broad knowledge of manufacturing processes.

• Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.

• Understands Fundamentals of Engineering Principles.

• Ability to effectively manage time and manage priorities to meet deadlines.

• Ability to handle multiple task assignments.

• Ability to interpret Corporate, Division and Department Procedures.

• Ability to work with minimal supervision.

• Ability to work in a team.

EDUCATION and/or EXPERIENCE

• Prior laboratory experience desirable

• B.S. in Engineering, Engineering Technology, Science a minimum.

• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.

• Experience with Access Databases, Excel (PIVOT Tables and Charts) and complaint handling software (Trackwise or Pilgram)

Quality Engineer I

• Minimum 1 to 3 years of experience with regulated industry, including co-op/internship experience.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general technical procedures or government regulations. Ability to write simple reports and business correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

REASONING ABILITY

• This position requires good judgment. All product and process development are to be carried out according to the applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources.

• Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary.

• A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal.

• Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in lab environment. Specific vision abilities required by this job include close vision and color vision. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT

Minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings. This position works in a normal lab/office environment. The noise level in the work environment is quiet to moderate.

Work environment requires operating and maintaining laboratory test equipment and measurement instruments.

Hybrid Role - 3 days in office (Tuesdays and Thursdays REQUIRED) with core hours 9:00AM to 3:00PM.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

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.

PDN

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift