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Validation Engineer

Remote:

Full Remote

Contract:

Full time

Salary:

15 - 15K yearly

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

6+ years of experience with Bachelor's OR 4+ years of experience with Master's in Science or Engineering, Knowledge of Quality principles, FDA QSR/QMSR, ISO standards, and combination devices, Experience in medical devices, clinical and commercial products.

Key responsabilities:

Provide quality oversight and support design transfer in commercial stage
Evaluate design changes, stay updated on regulatory requirements
Implement changes to controlled documents, execute quality process changes

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Provide Quality oversight for the Commercial stage, including Design Transfer.
Create/revise/execute SOPs to support combination product quality governance in the commercial stage.
Evaluate design changes and provide quality input to support continuous improvement initiatives.
Stay abreast of evolving regulatory requirements and ensure commercial 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 stake holders and CMOs.
Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve complex technical related drug device combination product, process and quality issues.
Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, WIs, etc.) as needed.
Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
Executes changes to quality processes to ensure conformance and continuous improvement.
Work with management and department personnel to achieve goals and strategic initiatives.
Supports due diligence and internal or external audits/inspections as needed.
Participate in annual product reviews and perform periodic review and update of DHF and RMF.
Support complaints investigations and filter information back to the design and development team and CMOs.

Requirements:

Must have 6+ years of relevant experience and a Bachelor's degree in a Science or Engineering related field; or 4+ years of relevant experience with a Master's degree in a Science or Engineering related field.
Medical device experience preferred.
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.