Job Description Summary

The Manager, Complaint Investigation, has the responsibility of administering the Field Assurance Quality Engineering functions for the facility which include Engineers and Engineering Technicians assigned to the BD UCC complaint investigation team. Quality results are expected to ensure the integrity of BD UCC complaint investigations. This includes the responsibility to maintain a department of well educated, trained, motivated and respected Quality Engineers and Quality Technicians to support the continuous improvement efforts. Oversee external teams working on UCC complaint investigations and ensure that UCC complaint expectations are met. The Manager, Complaint Investigation, will provide the team with tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional development for success.
Note: This is an In-Office position.

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. 

Job Responsibilities:

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

• Ensures the selection, orientation, development, and retention of qualified staff to carry out the responsibilities of the department.

• Provides support to Project Teams and Quality Department.

• Responsible for product testing in the Complaint Laboratory.

• Provides Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review and investigation.

• Performs and approves complaint investigations for UCC and OEM manufactured products.

• Creates investigation files in the BD UCC Global Complaint System (TrackWise).

• Supervises assigned complaint investigation files and works with the manufacturing sites to complete investigation timely and within UCC TAT (Turn Around Time) targets.

• Supervises the setup, safely operation, and maintenance of laboratory equipment and testing instruments.

• Ensures that tests and experiments are performed in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

• Develops and maintains a working knowledge of UCC procedures, ISO and FDA requirements.

• Maintains accurate data, analyzes and assists in drawing conclusions.

• Performs tasks accurately and with great attention to detail.

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

• Ensures compliance with UCC and global procedures.

• Collaborate with field assurance, manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups.

• May present data findings to peers, engineering, management staff, and auditors.

QUALIFICATIONS:

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

• Ability to lead a team with little or no direction from Quality Management.

• Ability to work with and supervise a team and provide guidance and constructive feedback to direct reports.

• At a minimum, intermediate level of knowledge of medical device regulation, industry or international standard.

• Ability to understand Quality Systems and be able to implement systemic changes to enhance processes and improve business efficiency.

• Ability to collaborate with regulatory bodies to present complaint investigation and technical information.

• Comprehensive knowledge of quality systems and relationship to business.

• Understanding of laboratory instrumentation.

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

• Ability to participate and provide quality leadership on improving teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. 

• Knowledge of Medical Device complaint reporting requirements.

• 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 priorities to meet deadlines.

• Ability to handle multiple task assignments.

• Ability to interpret Corporate and Department Procedures.

KNOWLEDGE and SKILLS: 

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

• 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 site, 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.

EDUCATION and EXPERIENCE:

• B.S. in Engineering, Engineering Technology, Science a minimum. Prior laboratory experience desirable.

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

• Minimum 8 years of experience with regulated industry and 3+ supervisory/management experience preferred.

• Proficiency with using MS Word, PowerPoint, and Excel (pivot tables, v-lookup, etc.).

• Experience with complaint handling software (such as TrackWise) preferred.

PHYSICAL DEMANDS:

• Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear.May occasionally lift objects up to 25 lbs. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

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

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

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift