Regulatory Compliance Expert

6 days ago

Phoenix, Arizona, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Engineering Consultant to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the company's medical devices meet all regulatory requirements and quality standards.

Key Responsibilities
  • Develop and Implement Quality Control Plans

Design and implement quality control plans, including sampling strategies, inspection protocols, and testing procedures to ensure compliance with relevant quality standards and regulations.

Ensure Regulatory Compliance

Ensure that all medical devices meet the requirements of relevant quality standards, regulations, and industry best practices, including ISO, FDA QSR, and cGMP.

Collaborate with Cross-Functional Teams

Work closely with manufacturing, design, and regulatory affairs teams to identify and resolve quality-related issues and improve the quality management system.

Perform Root Cause Analysis and Implement Corrective Actions

Conduct root cause analysis and implement corrective and preventive actions to continuously improve the quality management system and prevent quality-related issues.

Conduct Risk Assessments and FMEAs

Conduct risk assessments and failure mode and effects analyses (FMEAs) to proactively identify and mitigate potential quality risks.

Review and Analyze Quality Data

Review and analyze quality data to identify trends and areas for improvement, and provide recommendations for process improvements.

Participate in Design Reviews and Process Validations

Participate in design reviews, process validations, and other quality-related activities to ensure that all medical devices meet the required quality standards.

Assist in the Preparation of Quality Documentation

Assist in the preparation of quality documentation, including control plans, process flow diagrams, and validation reports.

Provide Technical Expertise and Training

Provide technical expertise and training to the quality engineering team to ensure that they have the necessary skills and knowledge to perform their duties effectively.

Requirements
  • Education

Bachelor's degree in Engineering, Quality Assurance, or a related field.

Experience

At least 5 years of experience in a quality engineering or quality assurance role within the medical device industry.

Skills and Knowledge

Demonstrated expertise in quality management systems, risk management, and process validation. In-depth knowledge of relevant quality standards, regulations, and industry best practices. Proficient in the use of quality management tools and software, such as SPC, FMEA, and validation documentation.

Personal Qualities

Strong problem-solving, critical thinking, and decision-making skills. Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams. Ability to work independently, adapt to changing priorities, and thrive in a fast-paced, dynamic environment.

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