Sr Quality Engineer I

Job Description

This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as pre-filled syringes and autoinjectors, to market. As the Sr Quality Engineer I, you will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team on Design Transfer. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products.

Roles and Responsibilities:

• Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve technical issues related drug-device combination product, process and quality issues.

• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation

• Writes and or implement changes to controlled documents (e.g., SOPs, Specifications, WIs, etc.) as needed.

• Create, revise, execute SOPs to support combination product quality governance during the Design Transfer or in the commercial stage.

• Work with management and department personnel to achieve goals and strategic initiatives.

• Executes changes to quality processes to ensure conformance and continuous improvement.

• Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.

• Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards.

• Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.

• Participate in annual product reviews and perform periodic review and update of DHF and RMF.

• Review design inputs, outputs, and verification/validation results.

• Analyze process data and ensure processes are capable and in control.

• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.

• Supports due diligence and internal or external audits/inspections as needed.

• Create and provide Quality training as needed for cross functional stake holders and CMOs.

• Support complaints investigations and filter information back to the design and development team and CMOs.

• Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards.

Knowledge, Experience & Skills

• Must have 6+ years of experience in the medical device industry and a Bachelor’s degree in science or engineering related field OR 4+ years of relevant experience with a Master’s degree.

• Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards.

• Previous experience with combination devices is preferred (i.e., Autoinjectors, pre-filled syringes).

• Previous experience in Design Transfer to contract manufacturers.

• Quality experience in both clinical and commercial products.

• Well-versed in risk management methodologies and their application.

• Able to work independently and in a global team environment, and with all levels of personnel within the organization.

• Possess excellent interpersonal relationship skills.

• Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives.

• Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred.

• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry- recognized professional organizations is preferred.