Analyst , Complaint Investigation

Job Description Summary 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 Med Tech 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.

This position is responsible for working in the Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. Quality results are expected to ensure the integrity of complaint investigations. Quality results are expected to ensure the integrity of BD UCC complaint investigations.

Note:

This is an In-Office position.

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

• Provides support to Project Teams and Quality Department.

• Responsible for all 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 complaint investigations for all UCC products and as applicable, for OEM manufactured products.

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

• Coordinates assigned complaint investigation files and works with the manufacturing site to complete the investigation timely.

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

• Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

• Develops and maintains a working knowledge of UCC policies and procedures and 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 policies.

• Ensures compliance to Department and Division procedures.

• Interfaces with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups.

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

• Technical competence in testing and writing and responsible for timely notifications based

• on new information received to FA specialists to meet FDA reporting requirements.

• Bachelor's degree preferred or Associate degree in a science field

• Prior laboratory experience desirable

• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) is a plus

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

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

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.

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

• 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…