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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 OVERVIEW

The QA Technical Specialist is responsible for providing sterilization technical support for thesterilizationgroupinconducting thevalidation activitiesforallBD Business Units whoseproduct issterilized by BD Interventional Sterilization as required. The QA Technical Specialist will support technical QA projects with execution and protocol/report writing as assigned. This position will support the routine monitoring equipment for EO Environmental programs and provide technical oversight of the equipment calibration program and document control in the Madison facility.Thisposition willassistinreviewandassemblingofsterilization DHRs for product release when necessary.

ESSENTIAL DUTIES AND Responsibilities

including the following. Other duties may be assigned.

• Support BD facilities / Business Units in sterilization validations and product launch activities by providing monitoring equipment and technical support.

• Maintains calibration and routine maintenance of the validation temp/RH monitoring equipment.

• Ensures compliance to divisional, Corporate, ISO, and EN requirements.

• Provides technical support for routine EO environmental safety programs including personnel monitoring and facility Baseline system.

• Writes all applicable protocols, reports, and procedures to support the QA technical applications to include Rotronics and QA projects as assigned.

• Assist QA Management in performing failure investigations.

• Revise and/or develop SOPs to support sterilization program.

• Support cost savings programs.

• Verifies DHR documents for accuracy and completeness prior to product release, when necessary.

QUALIFICATIONS

Toperformthisjobsuccessfully,anindividual mustbeabletoperform eachessential duty satisfactorily. The requirements listed below 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.

• Must possess the ability to work independently.

• Must be detailed oriented.

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

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

• ThoroughunderstandingofEOsterilization/validation.

• Have an understanding of process and equipment validation methodology with technical writing skills.

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

• Knowledge of hazardous chemical awareness. Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Microsoft Word, Excel, and Access.

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

• Forklift experience is preferred

EDUCATION and/or EXPERIENCE

• High School graduate (Associates or Bachelor's degree preferred)

• Preferred three years of experience in medical device or GMP regulated environment with process validation of medical devices, pharmaceuticals or biologics.

LANGUAGE SKILLS

• Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures.

• Ability to communicate ideas articulately.

MATHEMATICAL SKILLS

• Ability to apply mathematical concepts such as algebra, calculus, and statistics.

REASONING ABILITY

• Ability to effectively manage day to day decisions concerning sterilization projects.

• Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization. Judgment is essential.

• Determining what is absolutely vital and ensuring compliance with limited parameters is imperative.

• A high level of initiative is required. Day-to-day decisions about projects and validation programs are made frequently.

• Position will collaborate with internal and other division employees, contractors, and· regulatory agencies.