BD · 1 day ago
Advanced Quality Engineer I
Warwick, RI
Full-time
Onsite
Entry, Mid Level
1+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Advanced Quality Engineer I role involves ensuring product designs meet safety and efficacy standards while collaborating on new product development and addressing quality complaints.
Health CareMedical DeviceTechnical Support
Responsibilities
Technical Leadership & Mentorship - Provide expert guidance to Quality Engineers, Technicians, and Inspectors
Regulatory Excellence - Develop comprehensive test protocols and final reports that support critical regulatory submissions including 510K, PMA, CE mark, and international registrations
Innovation Partnership - Collaborate with our R&D teams to support Pre-Concept Front End Product Innovation Process activities, helping bring groundbreaking technologies to life
Project Leadership - Spearhead Quality Engineering initiatives aimed at enhancing our quality systems and procedures, driving continuous improvement across the organization
Risk Management - Create sophisticated design risk assessments while coordinating input from cross-functional team members and managing comprehensive risk files for medical devices
Design Verification & Validation - Develop robust protocols and detailed reports for both verification and validation processes, including critical data analysis and design acceptability decisions
Design Control Documentation - Contribute valuable insights to all phases of design control documentation as defined by our established product development process
Biocompatibility Expertise - Determine appropriate biocompatibility testing requirements per ISO10993 and company procedures, working alongside subject matter experts to coordinate testing and document results
Test Method Development - Create or enhance inspection and test methods aligned with product specifications, ensuring the highest quality standards
Shelf Life & Stability Studies - Design and execute comprehensive protocols and deliver detailed final reports supporting product expiration dating, Shelf Life and Stability Studies
Test Method Validation - Perform rigorous validations ensuring accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods critical for device safety and efficacy
Manufacturing Control Systems - Develop and document robust control systems for new products, including detailed inspection plans for components, sub-assemblies, and final products
Process Control Planning - Support the development of manufacturing control plans for both internal and outsourced processes, ensuring consistency and quality
Process Risk Assessment - Lead or support the development of thorough process risk assessments to identify and mitigate potential issues
Process Development - Conduct comprehensive studies to determine the acceptability of new processes or equipment, driving manufacturing excellence
Inspection Method Design - Create and qualify innovative inspection test methods and equipment to enhance quality control processes
Supplier Quality Management - Provide expert Quality Engineering support to outsourced analytical laboratories and manufacturing facilities, ensuring compliance with 21CFR 820, 210, 211; cGMPs, and ISO13485:2003 requirements
Supplier Qualification - Lead critical supplier part qualification activities including mold qualification and Design of Experiments (DOEs)
Production Transfer Support - Facilitate smooth process transfers to production facilities, ensuring quality is maintained throughout scaling operations
Quality Analytics - Generate detailed quality information reports showcasing trends and demonstrating the impact of process improvements
CAPA Implementation - Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances
Statistical Analysis - Perform DOEs and other advanced statistical analyses to support product and process optimization or determine causes of process variation, initiating corrective actions as needed
Technical Problem-Solving - Provide expert technical support to resolve quality challenges across development, pilot, manufacturing, or supplier operations
Quality Assurance Alignment - Support the strategic goals of the Quality Assurance Department, contributing to our culture of excellence
Qualification
Required
Bachelor Degree in Engineering or Technical Sciences and 2 years experience OR
Masters' Degree and 1 year experience in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving
A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability
Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs)
Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001
Proven track record of developing new products that meet customer expectations
Prior experience as a quality engineer lead on new product development teams
Prior experience interacting with Surgeons
Preferred
Prior experience with combination products and absorbable technologies a plus
Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred
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
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-20
Medical Device Network
2026-01-17
Company data provided by crunchbase