BD · 2 months ago
Advanced Quality Engineer I
USA RI - Warwick
Full-time
Onsite
Entry Level
2+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Advanced Quality Engineer I will represent quality on design teams and ensure that product designs and manufacturing processes meet corporate and divisional requirements, while actively collaborating on new product development and quality complaint investigations.
Health CareMedical DeviceTechnical Support
Responsibilities
Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors
Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations
Support Pre-Concept Front End Product Innovation Process activities for new technologies
Lead Quality Engineering Projects to improve Quality systems and Procedures
Develop design risk assessments, coordinating input from the other Design Sub-team members, and manage overall risk files for devices
Develop Final Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability
Develop Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability
Provide input into the project for all phases of design control documents as defined per Davol’s product development process
Determine the degree of Biocompatibility testing with assistance from biocompatibility SMEs required as per ISO10993 and company procedures. Co-ordinate the testing and document results
Develop or assist in development of inspection and test methods per product specifications
Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating
Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices
Develop shelf life and stability test protocols and reports as required
Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product
Support the development of manufacturing control plans for internal and outsourced processes
Support (or lead) development of process risk assessments
Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment
Design and qualify inspection test methods and equipment
Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, and ISO13485:2003 requirements
Lead supplier part qualification activities including mold qualification and DOEs
Support Process Transfers to the Production facilities
Organize and generate detailed quality information reports to show trends and the impact of process improvements
Support Process Transfers to the production facilities
Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering
Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances
Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required
Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted
Support goals of the Quality Assurance Department
Special projects as assigned
Qualification
Required
Bachelor Degree in Engineering or Technical Sciences
2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree 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
Good oral and written communication skills
Approximately 15 - 20% travel may be required
Preferred
Prior experience with combination products and absorbable technologies a plus
Prior experience as a quality engineer lead on new product development teams
Prior experience interacting with Surgeons preferred
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
EIN Presswire
2026-01-09
Company data provided by crunchbase