Sr. Quality Engineer - New Product Development

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.

RESPONSIBILITIES:

Project Leadership & Quality System Management

• Drive Quality Excellence- Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives
• Provide Strategic Leadership- Deliver expert Quality Assurance guidance for Project Teams and within the Quality Department
• Develop Critical Documentation- Build, review, and approve comprehensive Quality System Documents including CAPA and Audits that maintain our compliance standards

Technical Expertise & Product Quality

• Product Documentation Mastery- Craft, review, and approve detailed Product Documents including Design History Files that tell the complete story of our products
• Validation Excellence- Create and approve robust Protocols, Process and Product Validations, and Stability studies that ensure product reliability
• Risk Management Leadership- Develop sophisticated Risk Assessments including FMEA, FMECA, and FTA to proactively identify and mitigate potential issues
• Software Validation- Ensure all software components meet rigorous quality standards through comprehensive validation protocols

Team Development & Collaboration

• Mentorship- Guide and develop staff members, sharing your expertise to build our next generation of quality professionals
• Supervisory Responsibilities- Provide direction and leadership to technicians and engineers, fostering a culture of excellence
• Cross-Functional Collaboration- Work seamlessly with manufacturing facilities and other Division teams to ensure quality alignment

Quality Systems & Continuous Improvement

• Non-Conformance Resolution- Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans
• Quality System Auditing- Conduct thorough Internal and Supplier Quality System Audits to maintain compliance and drive improvement
• Quality Metrics Management- Track, trend, and analyze Quality Indicators to identify opportunities for enhancement
• Complaint Investigation- Lead thorough reviews and investigations of product complaints, ensuring appropriate resolution

Industry Leadership

• Professional Engagement- Actively participate in trade and professional organizations, ensuring our team stays at the forefront of industry standards and best practices
• Independent Review Leadership- Serve as an Independent QA Reviewer and Chairperson for Design Reviews, providing critical oversight

Required Qualifications:

• BS Degreein Engineering, Science or Technical Field

• 3 years of Quality Design Engineering experience in a regulated environment

• 5 years of experience in FDA regulated environment

Preferred Qualifications:

• Capital system experience (Electro-mechanical)
• ASQ Certification

Key Skills and Experience:

• College level mathematical skills.

• Basic applied statistics.

• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA

• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability

• Demonstrated history of successfully interpreting regulations, and procedures

• Demonstrated skill in statistical analysis and applied statistical methodologies

Reasoning Ability
Problems will be approached logically and methodically and be able to develop solutions and/or options. Judgment must be made by considering a few important facts. Written rules, precedents, and policies are available for guiding decisions, but are not always easily obtained. Decisions are made frequently, but are rarely needed immediately. As Design Control/ECR work and/or other responsibilities increase, so do the level of complexity and the importance of decision-making.

Physical Demands
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

• Office and manufacturing environments

• May include visits to clinical sites or hospitals.

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.

#BDCLO

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.

Required Skills

Optional Skills

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