New · posted Oct 20
Becton Dickinson · Medical Devices
Quality Engineer II, Instrument Plant
- Sparks, MD
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
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.
What you need
- 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.
Required Skills
Optional Skills
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 Qualificationsnice to have
- 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.
What you'll do
- 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
Pay
$75,800 – $121,300 a year
Employer providedSalary Range Information
$75,800.00 - $121,300.00 USD Annual
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.
Where you'll work
Sparks, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Sparks, MDWorking conditions
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.
Primary Work Location
USA MD - Sparks - 7 Loveton Circle
From the posting
About BD
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.
Equal opportunity, accessibility and legal noticesBecton Dickinson's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Maryland7 roles publishing pay
Senior & Principal roles in the US302 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $75,800 | — | $121,300 |
| Maryland (middle half) | $111,500 | $124,500 | $124,500 |
| All US (middle half) | $102,625 | $120,250 | $137,500 |
This role: Becton Dickinson's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not BD's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Lab testing and methods8
- Quality systems and risk8
- GMP and compliance6
- Investigations and CAPA6
- Documentation and SOPs5
- Data and digital systems2
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
BD on Regulatory Jobs
- 86
- Open roles
- 77
- Distinct roles
- 18
- Locations
By discipline
- Quality68 79%
- Regulatory16 19%
- Compliance & Safety2 2%
By level
- Senior & Principal42 49%
- Associate & Specialist26 30%
- Manager15 17%
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Quality Engineer II, Instrument Plant at BD
Open until filled. $76K–$121K a year, employer provided.