Job DescriptionWe 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.
Job Summary:The Quality Engineering II will support the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal procedures. This role will focus on improving product quality, processes, and overall customer satisfaction within a life sciences manufacturing environment.
Job Responsibilities:- Lead and participate in investigations of non-conformances, deviations, and out-of-specification results, identifying root causes and implementing effective corrective and preventive actions (CAPA).
- Develop, review, and approve quality documentation including procedures, specifications, and test methods.
- Support validation activities for equipment, processes, and software, including protocol and report generation and execution oversight.
- Perform risk assessments and develop mitigation strategies to ensure product quality and patient safety.
- Contribute to internal and external audit programs, including participation in audit preparation, execution, and follow-up activities.
- Analyze quality data and trends to identify areas for improvement and propose solutions.
- Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs) to integrate quality by design principles throughout the product lifecycle.
- Provide training and mentorship on quality principles and procedures to junior staff members.
- Ensure adherence to cGMP, ISO 13485, FDA, and other applicable regulatory standards.
Job Qualifications:- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- 3-5 years of experience in a Quality Engineering role within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology).
- Strong understanding of Quality Management Systems (QMS) principles and practical application.
- Demonstrated experience with root cause analysis methodologies (e.g., 5 Whys, Fishbone diagrams) and CAPA implementation.
- Familiarity with statistical process control (SPC) and other quality improvement tools.
- Excellent written and verbal communication skills, with the ability to effectively present technical information.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team in a fast-paced environment.
- Knowledge of ISO 13485 and FDA 21 CFR Part 820 regulations is highly preferred.
- ASQ certification (e.g., CQE) is a plus.
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.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
Work ShiftUS BD 1st Shift 9am - 5pm (United States of America)
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information$95,900.00 - $153,400.00 USD Annual
