What are the responsibilities and job description for the Design Quality Engineer position at TekOne IT Services Pvt. Ltd.?
Key Responsibilities
- Cross-Functional Collaboration: Engage with cross-functional teams in system and product continuous improvement projects to enhance design quality.
- Design Documentation Review: Review modified product design documentation, focusing on quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
- Risk Management: Review risk management documents and conduct change impact assessments for product design modifications, ensuring thorough evaluation of change requests.
- Statistical Analysis: Perform statistical analyses on data generated, including process capability (Cpk, Ppk), Gauge R&R, ANOVA, sample size determination, and variable/attribute data analysis against predetermined acceptance criteria.
- Technical Problem Solving: Analyze data, prepare reports on findings, identify trends, and propose corrective actions as needed.
- Mentorship: Mentor junior quality engineers, providing guidance and support in quality engineering practices for medical device products.
- Innovative Solutions: Independently develop imaginative, thorough, and practicable solutions to complex challenges, aligning with organizational objectives.
- Regulatory Compliance: Ensure that product development projects and modifications to existing products comply with FDA Quality System Regulations, EU MDR, and internal standards.
- Experience:
- Proven experience in leading process improvement methodologies (e.g., Lean, Hoshin, Six Sigma).
- Regulatory Knowledge:
- Strong understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Parts 803, 806, and 820) and medical device process requirements.
- Education:
- Master’s degree in science, engineering, or a related field is required; PMP Certification is preferred.
- Analytical Skills:
- Strong statistical analysis skills and experience with quality engineering tools and methodologies.
- Communication Skills:
- Excellent verbal and written communication skills, with the ability to collaborate effectively with cross-functional teams.
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