Job Description Summary

The Quality Assurance Manager for the Covington BD Interventional Sterilization (BDIS) site is responsible for the compliance of the Quality Systems at the site to meet the BD Corporate, Business Unit, and industry standards for quality system requirements for terminal sterilization processing for BD products. The QA Manager is the main contact for quality related issues, product release requirements, corrective action/preventive action programs, process improvement projects, and compliance programs within BD Interventional Sterilization. This job requires the manager to be onsite 5 days a week to support the operation of the sterilization site.

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 include the following.  Other duties may be assigned.

• Manages all aspects of the quality system within Covington BD Interventional Sterilization to include supervision of the lot release QA personnel, Quality Engineer(s), and QA Specialists (as applicable).

• Ensures compliance to Business Unit, Corporate, AAMI, ISO and EN requirements and maintains all sterilization QA related procedures and processes.

• Assist in development of strategic initiatives related to BD Sterilization Operations at the Covington site.

• Participates and leads Regulatory agency (EPA, OSHA, FDA, and ISO) visits/audits.

• Works with the Validation/Technical team and/or Global Sterilization (GSA) team for product on-loads into the Covington sterilization site.

• Coordinates completion of BD Interventional Sterilization adoptions as needed with the project teams, GSA, and the Validation/Technical team.

• Assists Validation/Technical team with cycle development and validation scheduling, as required.

• Oversees updates of sterilization specification sheets and works with the QA heads for the various manufacturing sites/Business Units to obtain approvals.

• Manages improvement projects, sterilization CAPA program, and timely disposition of nonconformances.

• Oversees the EO Personnel monitoring program for the site.

• Performs supplier audits as needed.

• Other duties as assigned by Director of Quality Assurance.

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.

• Must possess the ability to work independently and provide leadership to others, including both exempt and non-exempt staff.

• Must be detail oriented and able to manage time appropriately.

• Must possess knowledge about the physical, chemical, and biological sciences.

• Must understand impact of environmental control packaging, and manufacturing process on sterility assurance.

• Thorough understanding of Ethylene Oxide sterilization validation methods.

• Must have a strong understanding of medical device quality management systems and medicinal product quality management systems.

• Must be current on government regulations and international regulations regarding the sterilization of medical devices.

• Knowledge of hazardous chemical handling.

• PC literate, able to work with basic computer software programs (Microsoft Word, Access, and Excel). Knowledge of Statistical software.

• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building.

EDUCATION and/or EXPERIENCE:  

• Minimum of a Bachelors degree in an engineering or biological science.  

• Minimum of five (5) years experience in medical device industry.

• Three (3) years of experience with Ethylene Oxide sterilization of medical devices preferred.

• Minimum of five (5) years of supervisory or management experience.<