Job Description Summary

SUMMARY:
The Quality Assurance (QA) Specialist works in the Quality Systems (QMS_ area and oversees quality system requests and systems. The QA Specialist is the point of contact for the Madison BD Interventional Sterilization (BDIS) Quality System elements such as the purposes of quality system processes, regulatory compliance, and other business needs.

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):
•    Coordinate the fulfillment of Madison BDIS QMS requests.  These requests include, but are not limited to:
o    Regulatory and Quality System information
o    Quality system documentation
•    Serve as a subject matter expert on quality system processes.  Research, analyze and communicate with requestors as needed to ensure requests are fulfilled accurately and in a timely manner.

•    Serve as the site’s NC leader and process owner. Participate in the Material Review Board (MRB) process and develop and manage site’s nonconformances and metrics.
•    Serve as the site’s CAPA leader and process owner. Participates in the BD UCC CAPA Review Board process and develops and manages site’s CAPA Review Board (as applicable)
•    Serve as the site’s SME for the Electronic Document Management System, Electronic Nonconformance System, and Electronic DHR system.
•    Collaborate with process owners with other manufacturing sites or Business Units to secure customer requested information.
•    Determine and pursue courses of action necessary to obtain desired results. 
•    Plans and participates in disciplines strategically relevant to the business and/or functions

 •    Liaison with QA Manager, Operations Management, and Lot Release teams to identify and investigate QA related sterilization issues.
•    Track, maintain and manage QMS Documentation Requests.
•    Manage and maintain records in compliance with record retention requirements.
•    Assist other members of Quality Systems team via cross training as needed.
•    Other departmental/process improvement projects as required.

QUALIFICATIONS:

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

•    Proficient in the use of a personal computer with intermediate level of keyboarding skills with proficiency in Microsoft Word, Excel, PowerPoint and Access.
•    Proficient in the use of Electronic Data Management systems.
•    Detailed oriented and strong organizational skills.
•    Strong communication, customer service, writing, analytical and problem-solving skills. 
•    Ability to independently research and organize technical (QA/RA) product information for requests.
•    Ability to be flexible in a fast-paced environment.
•    Ability to multitask and prioritize effectively. 
•    Ability to apply common sense understanding to carry out instructions furnished in oral, written, or diagram form.  
•    Ability to solve practical job-related problems while working independently with minimal supervision.

EDUCATION and/or EXPERIENCE:

•    Bachelor’s degree preferred.
•    One (1) to three (3) years of related experience working with controlled documents or data management and/or training within a regulated industry required.
•    Familiarity with technical wording and documentation.

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 hel