BD · 2 hours ago
Sr. Quality Manager - New Product Development
Sparks, MD
Full-time
Onsite
Senior Level, Lead/Staff
$144K/yr - $238K/yr
10+ years expBD is one of the largest global medical technology companies in the world, committed to advancing the world of health. The Sr. Quality Manager will lead quality design assurance for reagents within the Global Product Development System, ensuring that products meet the highest standards of excellence while leading a dedicated team and collaborating globally.
Health CareMedical DeviceTechnical Support
Responsibilities
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
Qualification
Required
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
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
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
Strong knowledge of software quality and reliability engineering
An In-Vitro-Diagnostic Knowledge
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
Medical Device Network
2026-01-17
2026-01-16
Med-Tech Insights
2026-01-16
Company data provided by crunchbase