Job Description Summary

The Sr. Quality Manager will report directly to the Director of Quality – New Product Development.

The Senior Quality Manager, will spearhead quality design assurance for reagents within our Global Product Development System (GPDS).

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.

Job Summary:

In this pivotal role, you'll develop and implement sophisticated design control and quality assurance processes across Class I-III instruments and reagents, ensuring our products meet the highest standards of excellence.

You'll lead a dedicated team of direct reports in the US while collaborating with global development and manufacturing activities. As the quality champion of development core teams, you'll ensure customer expectations are not just met but exceeded, while maintaining unwavering alignment to applicable regulations.

Your expertise will be instrumental in continuous quality process improvement, with a special focus on reagent development while maintaining crucial interactions with instrument and software development groups.

Key Responsibilities for this Role: 

• Ensure effective execution of the quality engineering activities in support of new product development.

• Lead, develop, engage and mentor quality design assurance organization.

• Continuously improve quality processes and quality system with the goal of improving product quality, cost and customer satisfaction through implementation of DFSS, DFM, Risk Management and Reliability Engineering guidelines.

• Complete design transfer activities among manufacturing plants.

• Ensure effective and compliant quality operation for engineering change management, and other relevant aspects of the quality system as it relates to New Product Development activities.

• Lead implementation and utilization of quality tools such as six sigma, risk management, root cause analysis, and DOE.

Required Qualifications:

• Bachelor of Science in Engineering, Science (Chemistry, Physics, etc.), or other relevant field.

• 10 years of quality assurance or relevant experience. 

• Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa and others.

Preferred Qualification:

• Professional certification (i.e, CQA, CQE, SQE, CQM, Etc)

• 5 years of quality experience in new product development

• Master of Science in Engineering, Science, Business Administration

Required Skills and Knowledge:

• The ability to make timely critical decisions regarding product quality and/or quality system compliance.

• The ability to effectively lead teams and influence.

• A thorough understanding of 21 CFR §820, ISO 13485, and ISO 14971.

• The ability to prepare, and understand technical documentation such as Engineering Drawings, Quality System Procedures, Technical/Validation Studies, etc.

• The ability to assess and articulate risk when evaluating a situation.

• The ability to perform thorough investigations, identify the root cause(s) of an issue, and propose appropriate corrective action(s).

• The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.

• Knowledge of WW medical device regulations and quality sciences with specific focus on Class III design. 

• Excellent leadership, communication, organization and project management skills.

• Strong knowledge of design controls and risk management.

• Excellent knowledge of quality engineering sciences.

Preferred Skills and Knowledge:

• Strong knowledge of software quality and reliability engineering

• An In-Vitro-Diagnostic Knowledge

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 - 52/54 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

$143,900.00 - $237,600.00 USD Annual