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Katalyst Healthcares & Life Sciences is Hiring a Quality Engineering Consultant Near Phoenix, AZ
Responsibilities:
Our client, a leading medical device manufacturer, is seeking a mid-level Quality Engineering Consultant to join their team on a contract basis. In this role, you will be responsible for providing expert-level quality engineering support to ensure the company's medical devices meet all regulatory requirements and quality standards.
Develop and implement quality control plans, including sampling strategies, inspection protocols, and testing procedures
Ensure compliance with relevant quality standards, regulations, and industry best practices (e.g., ISO 13485, FDA QSR, cGMP)
Collaborate with cross-functional teams, including manufacturing, design, and regulatory affairs, to identify and resolve quality-related issues
Perform root cause analysis and implement corrective and preventive actions to continuously improve the quality management system
Conduct risk assessments and failure mode and effects analyses (FMEAs) to proactively identify and mitigate potential quality risks
Review and analyze quality data, and provide recommendations for process improvements
Participate in design reviews, process validations, and other quality-related activities
Assist in the preparation of quality documentation, including control plans, process flow diagrams, and validation reports
Provide technical expertise and training to the client's quality engineering tea
Requirements:
Bachelor's degree in Engineering, Quality Assurance, or a related field.
5-7 years of experience in a quality engineering or quality assurance role within the medical device industry
Demonstrated expertise in quality management systems, risk management, and process validation..
In-depth knowledge of relevant quality standards, regulations, and industry best practices (e.g., ISO 13485, FDA QSR, cGMP).
Proficient in the use of quality management tools and software, such as SPC, FMEA, and validation documentation.
Strong problem-solving, critical thinking, and decision-making skills.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Experience in leading quality improvement projects and driving continuous improvement initiatives.
Ability to work independently, adapt to changing priorities, and thrive in a fast-paced, dynamic environment.