BD · 1 month ago
Analyst I, Complaint Investigation
USA GA - Covington BMD
Full-time
Onsite
Entry Level
1+ years expBD is one of the largest global medical technology companies in the world, focused on advancing health solutions. The Analyst I, Complaint Investigation role involves performing product testing in the Complaint Laboratory, ensuring the integrity of complaint investigations, and providing support to project teams and the quality department.
Health CareMedical DeviceTechnical Support
Responsibilities
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
Qualification
Required
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
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 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 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
This position requires good judgment
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
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase