R&D Sr Quality Engineer, Design Assurance I (Part-time 20 hrs wk) - South Jordan, UT

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Written by AI from the job title and company, not by Merit Medical Systems, Inc., so some details may not match this job. The employer's own page has the real description.

Job Overview

The R&D Sr Quality Engineer, Design Assurance I position at Merit Medical Systems, Inc. is a part-time role that requires a dedicated professional to ensure the quality and reliability of medical devices. The incumbent will be responsible for implementing quality assurance methodologies throughout the design and development stages. The role encompasses close collaboration with cross-functional teams to ensure compliance with industry regulations and company standards, ultimately contributing to the safety and effectiveness of our innovative medical products.

Job Responsibilities

• Develop and execute design assurance strategies for new product development projects.
• Perform design reviews and provide feedback to engineering teams to align product designs with regulatory requirements.
• Participate in risk management activities, including FMEA and risk assessments.
• Ensure validation and verification activities are conducted and documented as per relevant standards.
• Collaborate with quality teams to resolve issues related to product design and compliance.
• Support internal and external audits by providing necessary documentation and evidence of quality practices.
• Conduct trend analysis of quality metrics and contribute to continuous improvement initiatives.

Qualifications

• Bachelor's degree in Engineering, Science, or a related field.
• Minimum of 5 years of experience in quality assurance within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and design control processes.
• Experience in risk management and Design Failure Mode Effects Analysis (DFMEA).
• Proficiency in quality tools and methodologies such as CAPA, SPC, and Six Sigma.
• Excellent analytical skills and attention to detail.
• Strong communication and interpersonal skills, with a collaborative approach to problem-solving.

Technologies & Tools

The R&D Sr Quality Engineer will utilize various technologies and tools in their role, including cloud-based quality management systems, electronic design and documentation platforms, statistical analysis software, and CAD design tools. Familiarity with project management tools and software such as Microsoft Project or similar will also be advantageous for effective collaboration within engineering teams.

Ideal Candidates

The ideal candidate for this position is a detail-oriented professional who possesses strong organizational and multitasking skills. They should have a proactive attitude towards quality and compliance, demonstrated by a commitment to maintaining high standards throughout the product development process. Successful candidates will be adaptable and capable of navigating challenges, while fostering strong relationships across diverse teams. A passion for innovation and a desire to contribute to the advancement of healthcare solutions are essential attributes for this role.