Job Description Summary

The Quality Engineer II is responsible for the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems. The Quality Engineer II uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools. Works with variable enterprise systems/Corporate directives to support new and/or current product lines and processes. Typical assignments may include, supporting one or more instrument platforms on sustaining items such as complaints, non-conformances and day to day issues, supporting audits, actively participating on teams, ensures documentation compliance, processing of CAPAs, change controls, and deviation waivers. Frequent interaction with other functional areas such as Research and Development, Operations, etc. is routine. The Quality Engineer II may take the lead in root cause investigations for issues of moderate complexity.

Job Description

We 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. 

Responsibilities

• Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle.

• Develop Device History Files and maintain in a manner consistent with regulatory requirements.

• Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers.

• Supports the coordinated integration of new products into Manufacturing / Operations.

• Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.

• Understanding and coaching others on Quality Systems and procedures.

• Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools.

• Cost Center Specific:• Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision.

• Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations.

• Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills.

• Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred.

• Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred.

Education and Experience:

• Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role. An advanced degree can make up for experience requirement.
• 2+ years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
• Experience in a medical device or pharmaceutical manufacturing facility.
• Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
• SAP transaction experience.
• Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003

Knowledge and Skills:

• Familiarity with supplier management, especially SCARs and driving change
  • Preferable contract manufacturing familiarity
• Risk management and risk-based decision making
  • Familiarity with DHF, DMR, HA, pFMEA, dFMEA, RMP/RMR/BRA
  • Risk as part of design change - standing up for quality
• CAPA and/or process improvement background
  • Meeting deadlines, achieving effective solutions
  • Validation involvement - such as a quality advisor/approver
• Familiarity with medical device regulations and working in a regulated environment
  • Preferable first-hand experience with audits
  • Preferable familiarity with manual assembly manufacturing
  • Preferable familiarity/background in microbiology/molecular science
• Complaint investigation / PMS activities
• Data analysis / efficiency
  • Able to effectively use Excel / PowerPoint / other tools to collect/analyze information

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?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

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.

Required Skills

Optional Skills

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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$73,300.00 - $121,000.00 USD Annual