Job Description Summary

The Staff Quality Engineer II is responsible for leading and maintaining the Post - Market Surveillance program in compliance with EU MDR, EU IVDR, Health Canada, China and UKCA requirements. This role ensures continuous monitoring of product performance, safety, and regulatory compliance throughout the product lifecycle. The individual collaborates cross-functionally with Regulatory Affairs, Medical Affairs and Marketing to collect, analyze and report post-market data.

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. 

We're seeking a diligent quality professional to join our team in a critical role ensuring product safety and compliance in the medical device industry. 

Responsibilities

• Lead Post-Market Surveillance Activities: Oversee the collection, analysis, and reporting of post-market data to ensure continued product safety and performance.
• Mentor and Coach Team Members: Provide expert guidance on technical principles, quality sciences, and regulatory compliance to develop junior team members.
• Solve Complex Technical Challenges: Apply creative thinking and technical expertise to address sophisticated quality issues that impact product safety and compliance.
• Contribute to Management Reviews: Provide critical insights and data analysis to inform strategic decision-making processes.
• Lead Quality System Audits: Plan and complete comprehensive audits to ensure compliance with internal and external requirements.
• Drive Continuous Improvement: Identify trends and opportunities from post-market surveillance data to enhance product quality and safety

Skills

• Regulatory Knowledge: Extensive understanding of FDA medical device regulations (21 CFR Part 820), ISO standards (13485, 14971), and international requirements (MDSAP, EU MDR/IVDR).
• Quality Systems Experience: Deep familiarity with corporate and unit-specific quality requirements in the medical device industry.
• Independent Work Style: Self-motivated professional capable of determining priorities and driving complex projects with minimal supervision.
• Leadership Capabilities: Demonstrated ability to provide guidance to junior associates and lead multi-functional teams.
• Subject Matter Expertise: Recognized as a site/functional expert in quality systems with the ability to represent the department in extended team initiatives.

Technical Proficiencies

• Quality Tools & Methodologies: Expertise in statistical process control, measurement system analysis, quality planning, and failure analysis investigation.
• Data Analysis: Proficiency with descriptive statistics, process capability analysis, and visualization tools (Pareto charts, box plots, histograms, scatter diagrams).
• Risk Management: Experience applying risk assessment methodologies to medical device quality systems.
• Auditing: Demonstrated capability in planning and conducting thorough quality system audits.
• Post-Market Surveillance: Specialized knowledge in collecting and analyzing real-world product performance data

Required Qualifications

• Bachelor’s degree in science, engineering, or other related field and 12 years relevant experience

Preferred Qualifications

• Master's degree in science, engineering, or other related field and 8 years relevant experience

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 NJ - Franklin Lakes

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

$130,400.00 - $215,200.00 USD Annual