QA Technical Specialist

Becton Dickinson Medical Devices•Madison, WI

11d•Onsite

About The Position

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. JOB OVERVIEW The QA Technical Specialist is responsible for providing sterilization technical support for the sterilization group in conducting the validation activities for all BD Business Units whose product is sterilized 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. This position will assist in review and assembling of sterilization DHRs for product release when necessary.

Requirements

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.
Thorough understanding of EO sterilization/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.
High School graduate (Associates or Bachelor's degree preferred)
Excellent written and verbal communication skills.
Ability to prepare technical reports and write technical procedures.
Ability to communicate ideas articulately.
Ability to apply mathematical concepts such as algebra, calculus, and statistics.
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.
This position entails regular sitting, object manipulation, sensing, arm extension, and verbal communication.
Standing and walking are regular activities for the employee.
The employee is required to climb or balance and stoop, kneel, crouch or crawl.
Must be capable of lifting at least 25 pounds.
Specific vision abilities required by this job include close vision and distance vision.
This position works in a normal office environment.
The noise level in the work environment is quiet to moderate.

Nice To Haves

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

Responsibilities

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.

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