BD · 5 months ago
Sr. Mgr, Quality Engineering (Electromechanical)
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$158K/yr - $261K/yr
10+ years expBD is one of the largest global medical technology companies in the world. The Senior Manager of EMI Quality Sustaining Engineering is responsible for planning and execution of Sustaining Engineering activities to ensure product compliance and improve customer experience.
Health CareMedical DeviceTechnical Support
Responsibilities
This leader will provide input into and support the Director of EMI Quality development of the overall EMI sustaining quality strategy
This leader will work with the respective BU platform teams when a design change is needed in support of sustaining projects
This leader will drive the customer facing lens of quality with a focus on instrument performance at install and while in the field
They will drive teams to deliver on improvements to drive improvement instrument reliability
This leader will develop quality programs to oversee and foster: process capability, new products supplied component readiness and introduction, product enhancements, material changes, operations quality and supplier quality expert-level leadership and guidance for a dedicated team
Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them
Actively identify improvements to the processes within the QMS to enhance both compliance and quality
Provide expert-level understanding of qualification and validation, nonconformance control, process capability, risk reduction, and supplier management requirements and how to deploy them in a large-scale and rapidly evolving business
Provide operations and quality leadership during FDA and notified body site inspections
Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information requests
Acquire and develop excellent-level leaders and teams to support the EMI mission and actively manage bench-strength and succession planning
Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate
Maintain effective design-related quality metrics and define and execute activities to improve performance
Actively support and demonstrate the BD values in daily work
Other assignments as directed by the Director of EMI Quality
Qualification
Required
Bachelor's degree in a technical field required
Minimum of ten (10) years' experience in Quality Assurance and Risk Management
Minimum of three (3) years' experience with electromechanical instrumentation devices
Minimum three (3) years of direct management experience, preferably with managing engineers
Working knowledge of (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR's (21 CFR Part 820)
Experienced in project management
Organizational / motivational skills
Capable of managing a range of projects and activities in parallel
The ability to manage by influence in addition to functional responsibility
The preparation, planning and presentation of key initiatives
The ability to coordinate effectively across regions
Preferred
Engineering degree strongly preferred
Master's degree in a technical field preferred
Benefits
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 help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
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
EIN Presswire
2026-01-09
Company data provided by crunchbase