BD · 1 day ago
Quality Engineer I
BD is one of the largest global medical technology companies in the world. They are seeking a Quality Engineer I to engage with quality networks, ensure compliance with regulations, and develop best quality practices while monitoring customer complaints and quality metrics.
Health CareMedical DeviceTechnical Support
Responsibilities
Engages with quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision
Ensure the plant/functional quality organization fulfills its obligations and aligns with applicable laws and procedures
Effectively navigate and help lead through the challenges of change and establish key stakeholder engagement focusing on solutions
Continuously evaluate progress toward tactical goals and objectives adapting them to meet customer and business needs
Development and implement best quality practices for areas of responsibility. Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards
Maintain positive and collaborative communication and collaboration with all levels of employees, customer, contractors, and vendors
Pursue and maintain a functional knowledge of global regulation affecting the local business
Demonstrate ability to influence without authority and deal effectively with ambiguity
Ability to develop solutions to assigned activities of low/moderate complexity. Strong communication, problem solving, organizational and interpersonal skills
Able to work self-direct by identifying and addressing risks within sphere of influence
This role will have primary focus on Plant Quality activities- including, but not limited to customer complaints, CID/CAPA, SA/FA, Quality metrics, Quality Notifications, Change controls, Post-Market, Planned Deviations and complaint data analysis
Responsibilities include monitoring, investigating and trending customer complaints for manufactured and distributed components/products
Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision-making processes to support predictable product design and flow
Initiates and/or supports CAPAs and may lead the investigation/corrective action process
Initiates and/or supports Situation Analysis and/or Field action process
Initiates and/or supports change notifications (change controls)
Responsible for the various aspects of IDAST QM Engineering as well as day-to-day QM Engineering responsibilities for assigned products and related operational area projects
Directly responsible to the Senior Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems
May support both internal and external audits as a Subject Matter expert (SME)
Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, and IVDR compliance. This includes using Enterprise tools to ensure compliance and streamline processes
Other duties as assigned based on business needs
Qualification
Required
Bachelor's degree in Engineering or Science
Minimum 3 yrs quality experience
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
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
Recent News
2026-01-22
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-20
Medical Device Network
2026-01-17
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