Job Description Summary

Senior Quality Engineer has responsibility for working independently, with cross functional teams or leading projects with minimal oversight. They are responsible for effectively interpreting the applicable Quality Systems policies, regulations and plant level procedures. Ensures that plant practices and product process and documentation are compliant. Assesses Critical To Quality (CTQ) parameters and makes risk assessments as part of the decision making processes to support product disposition.

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. 

Responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints. The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality. Develops, modifies, applies and maintains quality standards and protocols.

General Responsibilities:

• Initiates and/or supports CAPAs and may lead the investigation/corrective action process.

• Responsible for the various aspects of ID/AST plant sustaining, validation, & NPD Quality Engineering, including routine Quality Engineering responsibilities for assigned ID/AST products and quality system focus.

• Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to the product line. This includes assuring departmental compliance with ISO, IVDR and FDA requirements through supporting internal and external audits, participation on various cross-functional project teams, assigned project support, product launches, process improvements, and coordination/resolution of CAPAs, quality notifications, supplier management and change notifications.

• Uses tools for risk analysis/management, 8D, validation, and project management, sampling plans, Six Sigma, control plans, design control and trending.

• Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes, and verifies effectiveness of changes.

• Develops and maintains efficient methods for regularly reporting status to management the product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements.

Minimum Requirement:

• Bachelor's Degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field with minimum of 5 years’ experience within the quality function or Master’s Degree with minimum of 3 years' experience in quality.

• Experience handling multiple projects simultaneously in a fast-paced environment.

• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

• Pharma/Medical device industry experience preferred.

• Experience with Minitab or other statistical analysis platforms preferred.

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.

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