BD · 7 hours ago
Staff Quality Engineer (Process Validations)
USA CA - Milpitas 155
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $215K/yr
5+ years expBD is one of the largest global medical technology companies in the world. The Staff Quality Engineer will provide critical quality engineering direction to projects, oversee new product transfers to manufacturing, and ensure compliance with regulatory requirements.
Health CareMedical DeviceTechnical Support
Responsibilities
Lead Facilities, Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ) for new product introduction and sustaining engineering projects
Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation, root cause analysis, FMEAs, risk mitigation, DOE/other process improvement tools, sampling and control plans
Applies technical principles, theories, concepts, techniques and quality sciences / tools. Follows company procedures and makes procedural updates
Demonstrates working knowledge and application of applicable regulatory, Corporate and/or Unit requirements
Is a Core Team member, or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects
Acts as Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files
Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement project
Supports appropriate CAPA activities to accomplish internal/external objectives
Mentor associates in Quality system concepts and documentation
Qualification
Required
Typically requires a bachelor's degree in science, engineering, or other relevant field and 5 years relevant experience or a combination of equivalent education and relevant experience
A minimum of 5 years of quality assurance or relevant experience. Experience should be in the Medical Device or Bioscience industry
Significant experience in Process validation, FDA regulations and ISO requirements
Staff QE should possess strong knowledge process validations and production and process controls
An individual in this role must have excellent leadership, communication, organization and project management skills
The ability to make timely critical decisions regarding product quality and/or quality system compliance
An expert understanding of quality engineering sciences and their application to Validation activities
A thorough understanding of 21 CFR §820, MDSAP, ISO 13485, ISO 9001 and ISO 14971
The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc
The ability to assess and articulate risk when evaluating a situation
The ability to perform thorough investigations, identify 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
Good communication and presentation skills, Project Management, Trackwise systems, SAP
Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors
Knowledge of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry, including FDA Quality Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971
In-depth understanding of the application of QS to the medical device industry
Must be able to balance a complex agenda, ability to multitask
Must be well organized and methodical. Partners with cross-functional stakeholders to drive resolutions
Preferred
ASQ certification desired
Benefits
Competitive package of compensation and benefits programs
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
2026-01-22
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