Medical Device Quality Engineer
2 months ago
Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the company's medical devices meet all regulatory requirements and quality standards.
Key Responsibilities- Develop and Implement Quality Control Plans
Develop and implement quality control plans, including sampling strategies, inspection protocols, and testing procedures to ensure compliance with relevant quality standards and regulations.
Ensure Compliance with Quality Standards and RegulationsEnsure compliance with relevant quality standards, regulations, and industry best practices, including ISO, FDA QSR, and cGMP.
Collaborate with Cross-Functional TeamsCollaborate with cross-functional teams, including manufacturing, design, and regulatory affairs, to identify and resolve quality-related issues.
Perform Root Cause Analysis and Implement Corrective ActionsPerform root cause analysis and implement corrective and preventive actions to continuously improve the quality management system.
Conduct Risk Assessments and FMEAsConduct risk assessments and failure mode and effects analyses (FMEAs) to proactively identify and mitigate potential quality risks.
Review and Analyze Quality DataReview and analyze quality data, and provide recommendations for process improvements.
Participate in Design Reviews and Process ValidationsParticipate in design reviews, process validations, and other quality-related activities.
Assist in the Preparation of Quality DocumentationAssist in the preparation of quality documentation, including control plans, process flow diagrams, and validation reports.
Provide Technical Expertise and TrainingProvide technical expertise and training to the client's quality engineering team.
Requirements- Bachelor's Degree in Engineering, Quality Assurance, or a Related Field
Bachelor's degree in Engineering, Quality Assurance, or a related field.
Years of Experience in Quality Engineering or Quality AssuranceYears of experience in a quality engineering or quality assurance role within the medical device industry.
Demonstrated Expertise in Quality Management SystemsDemonstrated expertise in quality management systems, risk management, and process validation.
In-Depth Knowledge of Quality Standards and RegulationsIn-depth knowledge of relevant quality standards, regulations, and industry best practices.
Proficient in Quality Management Tools and SoftwareProficient in the use of quality management tools and software, such as SPC, FMEA, and validation documentation.
Strong Problem-Solving and Communication SkillsStrong problem-solving, critical thinking, and decision-making skills, with excellent communication and interpersonal skills.
Experience in Leading Quality Improvement ProjectsExperience in leading quality improvement projects and driving continuous improvement initiatives.
Ability to Work Independently and Adapt to Changing PrioritiesAbility to work independently, adapt to changing priorities, and thrive in a fast-paced, dynamic environment.
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