Staff Quality Engineer - Instruments

Regulatory Jobs; Sparks Corner (MD); On-site; USD 118,000 - 189,000; Full time

Job summary

BD in Sparks, MD seeks a Quality Engineer to drive Quality System compliance and SOP development for instrument manufacturing. You will guide CAPA, supplier qualification, and data analysis while supporting audits and regulatory requirements.

The role emphasizes on-site collaboration (minimum four days per week) to foster cross-functional problem solving and accountability within a regulated healthcare environment.

Qualifications

• Bachelor's degree and 10 years experience in a regulated environment.
• Master's degree and 5 years experience in a regulated environment.
• 5 years of experience in Quality Engineering.
• Certification in ASQ-CQA/CQE, AAMI, AOAC, and/or Six Sigma (Green/Black Belt preferred).

Responsibilities

• Interpret and apply Quality System requirements and develop/maintain SOPs and policies within the instrument manufacturing plant.
• Make key decisions to support critical organizational objectives.
• Support diagnostic instruments throughout the product lifecycle including manufacture, distribution, and post-market surveillance.
• Lead major quality system and business initiatives as project manager and report status to leadership.
• Provide expert guidance across Quality System elements and drive continuous improvement (internal/external).
• Apply statistical tools and data analysis to identify trends, root causes, and drive corrective actions.
• Support internal and external audits, ensuring readiness and compliance.
• Deliver training and mentorship on Quality Principles across cross-functional teams.
• Identify issues that may delay products or projects and recommend actions.
• Ensure documentation processes are compliant with regulatory standards.

Skills

Quality engineering

CAPA

Six Sigma

Project management

Root cause analysis

Regulatory knowledge

Data analysis

FDA 21 CFR 820

ISO 13485:2016

Education

Bachelor's degree in a regulated environment

Master's degree in a regulated environment

Tools

Six Sigma tools

CAPA processes

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

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

Responsibilities:

• Serve as a highly visible quality professional responsible for interpreting and applying Quality System requirements and developing/maintaining/implementing Standard Operating Procedures (SOPs) and organizational policies within the instrument manufacturing plant
• Make key decisions and recommendations that target critical organizational objectives
• Support diagnostic instruments throughout the medical device life cycle, including manufacture, distribution, and post market surveillance
• Ensure the successful completion of major quality system and business initiatives, including serving as project manager and reporting status to leadership
• Provide expert guidance across core Quality System elements, including process control and supplier qualification, while identifying and driving continuous improvement opportunities (both internal and external)
• Expert in the use of statistical tools and data analysis techniques to identify trends and root causes, drive corrective actions, and resolve moderately complex quality issues effectively
• Support internal and external audit activities, ensuring readiness and compliance
• Apply advanced quality engineering principles, technical concepts, and quality science methodologies to deliver measurable and validated results
• Provide training and mentorship to other members of the Quality team as well as guidance on Quality Principles, policies, and best practices cross-functionally
• Identify issues that may delay products or projects and recommend appropriate actions
• Ensure all documentation processes are compliant with applicable regulatory and quality standards

Required Qualifications:

• Bachelor's degree and 10 years experience in a regulated environment.
• Master's degree and 5 years experience in a regulated environment.
• 5 years of experience in Quality Engineering
• Certification in at least one of the following: ASQ-CQA/CQE, AAMI, AOAC, and/or Six Sigma (Green Belt, Black Belt, etc. is preferred.

Knowledge and Skills:

• Significant track record of root cause determination and effective corrective / preventive action (CAPA) implementation.
• Ability and skill to effectively manage multiple tasks and lead the successful and timely execution of projects.
• Ability and skill to lead or manage (by influence) the Quality function for engineering projects, reliability concepts for complex systems, validation planning / execution, and continuous improvement projects using statistical sampling, six sigma root cause analysis tools and project management techniques.
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
• Skilled at using systematic analysis tools that include Six Sigma, root cause, failure analysis and risk assessment to gather critical information and diagnosis.
• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution.
• Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standards (ISO) 13485:2016.

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.

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 MD - Sparks - 7 Loveton Circle

Work Shift

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

$117,800.00 - $188,600.00 USD Annual