Quality Engineer II

Regulatory Jobs; Covington (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

BD is seeking a Quality Engineer to own QA, document control and design control within their product line. You will partner with Manufacturing, R&D, Product Development, and Quality to ensure compliance and drive product improvements.

Responsibilities include leading CAPAs, auditing, DHF/document development, and risk management while supporting new product development and process changes. Travel up to 15% may be required.

Qualifications

• Bachelor's degree in Engineering (BME or EE) required.
• 2 years of Quality Engineering experience in a regulated environment.
• Willingness to travel internationally up to 15%.

Responsibilities

• Lead Quality Assurance and Design Control activities for assigned product lines.
• Develop, review, and approve quality system documentation (CAPAs, audits).
• Create and approve DHFs and design documentation; validate protocols and reports.
• Investigate nonconformances; drive corrective and preventive actions.
• Perform and participate in internal and supplier quality audits.
• Monitor and trend quality metrics; partner with sites for continuous improvement.
• Chair Design Review activities and act as independent QA reviewer.

Skills

Quality Engineering

Design Control

Documentation Control

CAPA management

Risk management

FMEA / FMECA / FTA

FDA/regulatory knowledge

Statistical analysis

Travel up to 15%

Education

Bachelor's of Engineering (BME or EE)

Masters of Engineering

ASQ Certification

Tools

DHFs

Job description

We are the people who give possibilities purpose

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.

Job Description

Position Summary:

The Quality Engineer is responsible for a broad range of quality engineering activities and serves as the owner of Quality Assurance, Document Control, and Design Control processes within their product line. This role partners closely with Manufacturing, R&D, Product Development, and Quality teams to ensure compliance with quality system requirements while supporting new product development, product changes, process improvements, and ongoing quality initiatives.

Responsibilities:

• Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are applied throughout product and process changes as well as new product development activities.
• Provide Quality Assurance leadership and guidance to project teams and the broader Quality organization.
• Develop, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
• Create, review, and approve product documentation, including Design History Files (DHFs) and supporting design documentation.
• Develop, review, and approve validation protocols and reports, including process, product, and stability validations.
• Create, review, and approve risk management documentation, including FMEA, FMECA, and Fault Tree Analysis (FTA).
• Investigate product and process nonconformances and lead corrective and preventive action activities to drive sustainable improvements.
• Conduct internal quality system audits and supplier quality audits to ensure compliance with regulatory and company requirements.
• Review and investigate customer complaints as needed, ensuring timely and effective resolution.
• Monitor, analyze, and trend key quality metrics and performance indicators to identify opportunities for improvement.
• Partner with manufacturing sites and other division facilities to support quality objectives and continuous improvement efforts.
• Serve as the independent Quality Assurance reviewer and Chairperson for Design Review activities.

Required Qualifications:

• Bachelor's of Engineering (BME or EE)
• 2 years of Quality Engineering experience in a regulated environment
• Ability to travel internationally up to 15%

Preferred Qualifications:

• Masters of Engineering
• ASQ Certification

Knowledge and Skills:

• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA
• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability
• Demonstrated history of successfully interpreting regulations, and procedures
• Demonstrated skill in statistical analysis and applied statistical methodologies

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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.

Primary Work Location

USA GA - Covington BMD