Overview
Sr. Quality Engineer – Combination Products, QMS Compliance Jobs in Foster City, California, USA at Gilead Sciences, Inc.
Sr. Quality Engineer – Combination Products, QMS Compliance
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 vial kits and pre-filled syringes, to market. 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 and the Gilead network on Quality Assurance related activities.
We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products.
Roles/Responsibilities:
Provide Quality oversight for QMS development and maintenance.
Create/revise/execute SOPs and other controlled documents to support combination product quality governance throughout a combination product’s lifecycle.
Provide quality input to support continuous improvement initiatives.
Stay abreast of evolving regulatory requirements and ensure combination products comply with 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.
Create and provide Quality training as needed for cross functional stakeholders and CMOs.
Develop key relationships and interface extensively with internal stakeholders to address and resolve complex technical related drug device combination product, process, and quality issues.
Ensure that changes to combination products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.
Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
Work with management and department personnel to achieve goals and strategic initiatives.
Support complaints investigations and safety reporting. Work with internal stakeholders, including Patient Safety and Global QA/Complaints. Filter information back to the design and development team.
Support field-related activities, such as corrections and removals.
Initiate, manage and approve deviations and corrective/preventive actions.
Supports due diligence and internal or external audits/inspections as needed.
Support data gathering, analysis, and monitoring to support MDCP metrics for the department as well as Quality Management Review and Annual Product Quality Review requirements.
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, co-packaged kits, pre-filled syringes).
Quality experience in both clinical and commercial products.
Strong project management and process improvement 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 Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
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.
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Title: Sr. Quality Engineer – Combination Products, QMS Compliance
Company: Gilead Sciences, Inc.
Location: Foster City, California, USA
Category: Quality Assurance – QA/QC, Healthcare
