Job Description Summary

This position will act as the quality representative regarding quality interests and concerns on manufacturing project teams as well as involvement in a variety of projects which may include, resolving quality problems, improving areas of high-quality costs, assisting suppliers and subcontractors in meeting BD’s quality needs, and BD Excellence/Improvement projects.

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 creativity 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. 

Responsibilities

• Design and conduct Quality Engineering studies to resolve causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them.

• Provide technical support to resolve quality problems in manufacturing or with suppliers as warranted.

• May perform qualification studies (PPQ/PPAPs) for new suppliers, components, and inspection test equipment.

• Plan and implement validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.

• Provide detailed instructions for performance of Q.C. Inspections, including Inspection plans, Test Procedures, and Quality Standards.

• Evaluate customer's specifications for BD’s ability to comply.

• Support other manufacturing and business goals. Supply ideas to these programs and work on implementation.  Serve on committees, teams, task forces as assigned.

• Conduct other Quality Projects as assigned by the Quality Engineering Manager.

• Exercise control over the quality of conformance of the products generated in areas assigned.

• Completes Nonconforming material report (NCMR). This includes maintaining Grand Avenue (software) database and reporting to management.

• Reviews DHR documentation for compliance and release of components and finished product.

Education and/ or Experience Required:

• Bachelor’s Degree in Engineering or Technical Sciences.

• 2-3 years of experience in quality technology or engineering.

• In lieu of an Engineering degree, a Bachelors Degree with 5 + years of medical device Quality Engineering Experience.

• A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.

• Experience with Statistical software (Minitab).

• Good oral and written communication skills.

• Ability to work with and empower people. Ability to multi-task optimally

• Understanding of GMP, GDP, ISO 13485, MDD/MDR, QSR, and other applicable regulations, and the ability to interpret these as they apply to company issues.

• Good project planning skills and focused on meeting customer needs.

• Experience in medical device Class II/III environment preferred.

• Solid understanding of GMP and FDA regulatory requirements for Class III medical devices or equivalent

• ASQ Certified Quality Engineer preferred.

• ASQ Certified Quality Auditor preferred.

Physical Demands:

• Must be able to wear a respirator, if required.

• Must be able to stand, move, twist and bend to operate as required in clean rooms.

Work Environment:

• Quality Control, Micro and Chem Laboratories, Incoming and Product Released, Manufacturing Areas, Quality Systems

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.  

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA MA - Woburn

Additional Locations

Work Shift

NA (United States of America)