Job Description Summary

This position is responsible for auditing all official documents and assembling the Sterilization Device History Record. Ensures that all terminally sterilized products meet release criteria prior to the preparation and issuance of official release documentation. Responsible for receipt and issuance of all controlled documentation to the Regional Facility

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.

• Audits and reviews data for the preparation of the Sterilization Device History Record.  Documents to be reviewed, include but not limited, to Sterilization Process Sheets, Sterilization Tracking Sheet, Manufacturing Certificates, Pallet Tags and BI Test Reports.  Verifies for accuracy and completeness.

• Responsible for the release of terminally sterilized product once all release criteria have been satisfied. Ensures compliance to sterilization processing specifications.

• Responsible for receipt, issuance and maintenance of all controlled documentation at the Interventional Facility.

• Responsible for gathering data for special projects and reports.

• Reports all deviations from specifications to Quality Management or designate.

• Contribute to the Interventional Sterilization Tracking System Database.  Completes entry of release information to the database.

• Create non-conformances and ensure they are dispositioned prior to the release of product

• Periodically on a daily basis walk warehouse floor and monitor for compliance

• Perform overtime as needed

• Additional duties as assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential 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.

• Proficient in the use of a personal computer with intermediate level of keyboarding skills with proficiency in Word and Excel.

• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and must be able to work as part of a team.

• Strong listening and assessment skills.

• Must be able to prioritize and handle several projects concurrently.

• Self-motivated and detail oriented with ability to work independently.

• Excellent decision-making skills, strong organizational, follow through and time

• Detail-oriented, ability to reason and use sound judgment during review of records

EDUCATION and/or EXPERIENCE

• High School graduate or equivalent. Higher education a plus.

• Sterilization experience preferred.

• 1-2 years of quality experience preferred

• Auditing and quality control experience preferred.

• JDE/SAP experience preferred

LANGUAGE SKILLS

• Excellent written and verbal communication skills.

MATHEMATICAL SKILLS

• Basic mathematical skills required.

REASONING ABILITY

• This position requires a self-confident individual with the ability to foresee and avoid potential problems.  The employee must have the ability to detect patterns and trends.

PHYSICAL DEMANDS

While performing the duties of this job the employee is regularly required to sit, use hands to fingers, handle or feel, reach with hands and arms, and talk and hear.  Must have the ability to lift at least 25 pounds.  Specific vision abilities required by this job include close vision.  Reasonable accommodations may be made to enable those individuals with