Sr. Quality Engineer

Becton Dickinson Medical Devices•El Paso, TX

17h•Onsite

About The Position

The Sr. Quality Engineer is responsible for supporting Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform. The incumbent works multi-functionally with teams on change management projects (including those that may impact product design), design transfers, global expansion projects, risk management, process/product design and development, quality improvement projects (QIPs), and cost to win (CTW) projects.

Requirements

Bachelor's degree in Engineering from an accredited four (4) year university.
5 - 8 years Quality Engineering experience with pharmaceutical, combination products, or medical devices.
Experience operating in GLP, GMP, and GDP.
Attentiveness to details with strong organizational skills.
Ability to work proactively and independently.
Ability to multi-task and efficient in time management.
Excellent verbal communication and interpersonal skills.
Ability to work in a team environment.
Proficiency in Excel, Word, and other desktop/general business systems

Nice To Haves

Pharmaceutical or combination product experience, preferred.
ASQ Certified Quality Engineer (CQE), Six Sigma Black Belt (SSBB), or advanced degree preferred.
Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.
Experience with ERP systems and software such as SAP, preferred.

Responsibilities

Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
Lead Quality Engineering Projects to improve Quality systems and Procedures.
Support or leads change management activities including risk and design impact assessments.
Update and maintain product Design History File (DHF) & Drug Master File (DMF) based on change activities.
Development and maintenance of the Risk Management File in accordance with ISO14971, coordinating input from the other Design Sub-team members including the development of the design, process, and usability FMEAs.
Develop or assist in development and qualification of inspection and test methods and equipment.
Develop and document the Control Plan / 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 the PFMEA, Process Requirements Specifications (PRS), and Validation Plans and Protocols including developing statistical sampling requirements.
Perform and/or Support Process Development Studies to determine the acceptability of new processes or 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, CMC, and ISO13485 requirements.
Lead supplier part qualification activities including mold qualification and DOEs (PPAP).
Support Design / Process Transfers to the Production facilities as well as line expansion / capacity / productivity changes.
Supports new global expansion efforts for existing products.
Liaison between OUS quality and plant quality.
Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required.
Organize and generate detailed quality information reports to show trends and the impact of process improvements.
Conduct other Quality Control Projects as assigned by the Manager of Quality Engineering.
Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.
Perform DOE’s and other statistical analysis 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 / Engineering Department.
Mentor junior QE staff