BD Nogales Norte · 1 week ago
Staff Quality Engineer I
Franklin Lakes, NJ
Full-time
Onsite
Lead/Staff
8+ years expBD is one of the largest global medical technology companies in the world, focused on advancing health through innovative solutions. The Staff Quality Engineer I will support new product development and maintenance by applying quality engineering skills to ensure compliance with regulatory requirements and quality standards.
Consumer Goods
Responsibilities
Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results
Track record of root cause determination and effective corrective / preventive action implementation
Provides training for product development teams and continuous improvement team on best practices
Conducts audits as member of a quality system audit team (e.g. SME, etc.)
Writes and leads risk management activities including risk management reports and risk analyses
May perform other duties as required
Guides the successful completion of major programs and may function in a project leadership role
Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations
Decisions, recommendations and results further the achievement of goals critical to organizational objectives
Implements and communicates the strategic and technical direction for the product/project team
Identifies any issues that may delay product or project and recommends appropriate action to be taken
Support of the following areas, however are not limited to: Design Control, Design Input, Design Output, Design Verification plans, protocols, and reports, Design Reviews, Design Validation, Design History File support, Change control, Assessment of Change Request (ACR) Responses, Risk Management, Process Validations, Identification of CTQ's, Unit Quality Independent Reviewer During Design Reviews, Handling of deviations and non-conformances, Test method validations, Supplier qualification, Software validations, Post Market Surveillance, Situation Analysis, CAPA – Root cause investigation and implementation of corrective / preventive actions, Proper Use of Statistics (Sampling Plans), Advise on Regulations, Liaise with Manufacturing Plants, Provide functional support to cross-functional teams, Internal and external audits, Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements, Training in design of experiments and statistics, Ability to support internal / external audits
Qualification
Required
Bachelor's Degree and 8 years relevant experience
Class II / III medical device experience
Preferred
Knowledge of six sigma methodology
Knowledge of design control principles
Certified Quality Engineer and Certified Quality Auditor
Company
BD Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte 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
Late StageCompany data provided by crunchbase