Job Description Summary

Responsible for ensuring that all raw materials and products batch records are reviewed and released in a timely manner and in compliance with all Quality requirements. Assist in Calibration, Environmental Monitoring Reviews and Preventive Maintenance Administrator. The Quality Specialist will support the Quality Systems such as: Audits, CAPA and Management Review. The Quality Specialist will serve as QC Inspector Back-up.

Duties involve using different procedures, requiring the use of judgment and analysis of facts to determine action to be taken within the limits of established acceptance standards. Additionally, requires a sense of urgency regarding matter of serving the customer and compliance 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 Position Responsibilities:

• Performs independent review of textile raw materials and subassemblies including yarns, fabrics, and tubular fabrics for conformance to specifications, including calculation of results using formulas and Excel spreadsheets. Ensures that all product lots meet the established in-process procedures, specifications and inspections, before his/her approval to release.

• Ensures that completed lot history records submitted for lot release review are secured prior to disposition. Responsible for timely completion of final product shipping authorization documentation.

• Maintain and file the lot history records and release activities documentation.

• Conducts Data and documentation review and analysis.

• Maintains receiving inspection, work in process and finished product DHR records, procedures, and specifications.  Review lot history folders for final lot release sign off and files them in the appropriate location.

• Review a database with all yarn and chemical re-test dates required by the specification.

• Assist in writing inspection and test procedures and other documents relevant to incoming/receiving inspection, work in process, finished product and Lot Release.

• Assists in-house calibrations. Maintains calibration log and coordinate calibration of the respective gauges and equipment.

• Assist in the environmental monitoring reviews.

• Support the Quality Systems such as: Audits, CAPA and preparation of the Management Review deck.

• Perform and maintain SCAR’s and MRN’s.

• Assist Quality Manager/Quality Engineer in data collection, review, analysis and reports as necessary (related to re-works, sorting, lot release, inspection process time studies and etc.).

• Reviews device history records and associated documentation in preparation for lot release to shipping, maintains lot release records with high degree of legibility, accuracy, neatness and organization.

• Follow established company rules and regulations, safety precautions, and maintain quality standards.

• Regular attendance and punctuality.

• Assist in maintaining supplier quality database. Perform data entry and generate monthly supplier history reports.

• Perform reviews and inspections of new and existing products as needed.

• Assist Quality Engineer by providing input for test procedures and test protocols.

• Maintain neat and accurate records for all testing performed.

• Computerize and analyze results of studies using software packages such as Windows, Excel, Word and Statistical analysis software.

• Perform other related duties as assigned.

Qualifications, Knowledge, and Skills Required:

• Associates degree in Sciences or related discipline or High School diploma and minimum 4 years of relevant Quality experience required

• Two or more years of experience working in a medical device or other regulated industry

• Must have ability to read, write, interpret, comprehend, and consistently follow specifications written in English

• Must have strong attention to detail

• Ability to manage multiple priorities and tasks in a dynamic environment

• Ability to work in a team environment

• Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required

• Good oral and written communication skills. Ability to coordinate work cross functionally.

• Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)

Position Type: Non-Exempt

Shift: Day shift

Reports to: Quality Control / QA Manager

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 help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. 

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA MA - Lexington

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)

Salary : $61,300 - $77,600