Quality Engineer II, Instrument Plant

BD; Glencoe (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

BD in Sparks, MD is seeking a Quality Engineer II to ensure compliance with ISO 9001, ISO 13485 and FDA regulations across design, manufacturing and testing. You will leverage Six Sigma tools, lead root-cause investigations, and support CAPAs while collaborating with R&D and Operations to build quality in from day one.

You’ll analyze data, manage device history files, and contribute to continuous improvement in a fast-paced medical device environment.

Qualifications

• Knowledge of quality systems and regulatory frameworks.
• Experience with Six Sigma and data-driven problem solving.
• Familiarity with medical device regulations (FDA, ISO 13485).
• Experience with audits and CAPA processes.

Responsibilities

• Maintain ISO and regulatory requirements across product lifecycle.
• Develop and maintain Device History Files per regulatory needs.
• Perform trend analysis and risk assessment to drive improvements.
• Lead root-cause investigations for moderately complex issues.
• Collaborate cross-functionally with R&D and Operations.
• Support new product integration with quality built in from day one.

Skills

Quality systems

Six Sigma

Data analysis

Regulatory knowledge

SAP

Audits

Education

Bachelor’s degree in Biological Sciences/Engineering

Tools

SAP

MS Office

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

As our Quality Engineer II, you’ll be the go-to expert for applying and interpreting plant and department procedures, ensuring we stay consistent and compliant with our Quality Systems. You’ll leverage sophisticated statistical and analytical tools while working across enterprise systems and corporate directives to support both new and existing product lines.

Responsibilities:

• Champion Quality Compliance: Maintain International Organization for Standardization (ISO) and regional regulatory requirements across the entire product lifecycle - from design and manufacturing to assembly, testing, inspections, and customer complaint resolution

• Master Documentation: Develop and maintain Device History Files in full compliance with regulatory requirements, ensuring every detail is captured and accessible

• Drive Quality Intelligence: Generate critical CTQ (Critical to Quality) indices and provide actionable recommendations and solutions to emerging issues for project teams, operations, and suppliers

• Lead Product Integration: Support the seamless integration of new products into Manufacturing and Operations, ensuring quality is built in from day one

• Ensure Regulatory Excellence: Guarantee that BD Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet all applicable regulatory requirements

• Mentor and Coach: Share your expertise by helping others understand and apply Quality Systems and procedures effectively

• Analyze and Optimize: Perform sophisticated trend analysis, risk management (including FMEA, Hazard Analysis, and Fault Tree analysis), and apply Six Sigma tools to drive continuous improvement

• Variety: Support one or more instrument platforms on sustaining activities including complaints, non-conformances, and daily operational challenges

• Leadership Opportunities: Take the lead on root cause investigations for moderately complex issues and make a tangible difference

• Cross-Functional Collaboration: Work closely with Research and Development, Operations, and other key departments - collaboration is part of your daily routine!

• Hands-On Problem Solving: Actively participate on teams, support audits, ensure documentation compliance, and process CAPAs, change controls, and deviation waivers

• Strategic Impact: Your work directly influences product quality and customer satisfaction across our entire portfolio

Education and Experience:

• Bachelor’s degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs.
• 2 years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
• Experience in a medical device or pharmaceutical manufacturing facility.
• SAP transaction experience.

Knowledge and Skills:

• Multi-task management and change management plan execution

• Conflict management and results-driven performance with minimal supervision

• Team collaboration and cross-functional coordination

• FDA 21 CFR 820 regulations (moderate knowledge, ISO 9000:2000 and ISO 13485:2003 standards (moderate knowledge), GLP/GMP/ISO requirements and Quality System regulations

• Medical device regulations and regulated environment experience

• Design Control requirements

• Medical Device Validations (preferred)

• Data analysis using Six Sigma, root cause analysis, failure analysis, and risk assessment (moderate to difficult complexity)

• Statistical methods and tools application

• Risk management and risk-based decision making

• Proficiency in Excel, PowerPoint, and statistical software packages

• First-hand audit experience (Preferred)

• Microbiology/molecular science background (Preferred)

• Data efficiency optimization (Preferred)

Preferred Qualifications:

• Manual assembly manufacturing experience
• Experience with microbiological and chemical test methods

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 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

$75,800.00 - $121,300.00 USD Annual