What are the responsibilities and job description for the Quality Engineer position at MediView XR, Inc.?
As a Quality Engineer, you will play a critical role in ensuring that our devices meet the highest standards of quality and safety from the initial design phase through to production. Your expertise will be vital in developing and implementing quality plans, incorporating quality into product design, conducting risk assessments, and ensuring compliance with regulatory requirements. This position offers an exciting opportunity to contribute to the advancement of life-saving technology and make a tangible impact on patient care.
DUTIES AND RESPONSIBILITIES:
- Quality Planning and Control:
- Develop and implement quality plans, standards, and procedures for new product designs.
- Collaborate with design and development teams to ensure that quality is built into the product from the beginning. This includes providing input into bench and pre-clinical test requirements, helping to identify design elements that are critical-to-quality, and participating in risk management meetings.
- Coordinate with other members of Quality Assurance to establish criteria for supplier manufacturing.
- Risk Management:
- Conduct risk assessments and failure mode and effects analysis (FMEA) to identify potential design issues.
- Develop mitigation strategies to address identified risks.
- Verification and Validation:
- Plan and execute design verification and validation activities, including testing and inspection of prototypes.
- Ensure that the product meets all specifications and regulatory requirements.
- Documentation and Compliance:
- Maintain detailed records of design reviews, test results, and quality control activities.
- Ensure compliance with industry standards and regulatory requirements (ex: ISO, FDA)
- Continuous Improvement:
- Analyze quality data and feedback to identify areas for improvement in the design process.
- Implement changes to improve product quality and reduce defects.
- Problem Solving and Root Cause Analysis:
- Investigate design-related quality issues and conduct root cause analysis.
- Develop and implement corrective and preventive actions.
- Cross-Functional Collaboration:
- Collaborate with other departments, such as manufacturing, procurement, and regulatory affairs, to ensure a holistic approach to quality.
- Training and Support:
- Provide training and support to design and development teams on quality-related topics.
- Promote a culture of quality within the organization.
- Perform all other duties as assigned
QUALIFICATIONS:
- Bachelor's degree in engineer, quality assurance, or related field preferred.
- Minimum of 3 years' experience in design quality engineering, preferably in medical device.
- Strong knowledge of design control processes, risk management, and regulatory standards.
- Experience with quality management systems, such as 21CFR Part 820, ISO 9001, ISO 13485, ISO 17025.
- Working knowledge of document control, EQMS, and other software platforms utilized within the medical device industry.
- Must be willing to travel 20-30% of the time with some overnight stays necessary.
- Must have the ability to lift and/or move up to 15 lbs.
