What are the responsibilities and job description for the Supplier Quality Engineer position at TekOne IT Services Pvt. Ltd.?
Role: Supplier Development Quality Engineer
Location: Pleasanton, CA - 94588
Duration: 12 Months
Shift: 8 AM to 5 PM
Key Responsibilities
Location: Pleasanton, CA - 94588
Duration: 12 Months
Shift: 8 AM to 5 PM
Key Responsibilities
- Evaluate and select suppliers based on rigorous quality standards, ensuring alignment with company and regulatory requirements.
- Conduct thorough audits and assessments to maintain high levels of compliance and quality performance among suppliers.
- Work closely with teams across engineering, manufacturing, and procurement to qualify materials and components, ensuring they meet required specifications and quality standards.
- Develop and implement comprehensive material qualification plans, including testing and validation processes.
- Track and analyze supplier performance metrics, focusing on quality, delivery, and responsiveness.
- Lead supplier improvement efforts, addressing non-conformances and driving corrective actions.
- Partner with suppliers to design and execute quality improvement plans.
- Develop and manage receiving inspection processes for incoming materials, ensuring alignment with company and regulatory standards.
- Investigate and resolve issues identified during the receiving inspection process, ensuring no disruptions to production.
- Contribute to the creation and maintenance of supplier quality engineering methodologies, systems, and best practices.
- Ensure all activities adhere to company policies and relevant regulatory standards, including FDA and ISO.
- Bachelor’s degree in Engineering, Quality, or a related field.
- Minimum of 3 years in supplier quality engineering or a related role within the medical device industry.
- Strong understanding of quality systems, regulatory requirements (FDA, ISO), and supplier management processes.
- Proven experience in conducting supplier audits, material qualifications, and implementing corrective actions.
- Exceptional problem-solving abilities, with a collaborative approach to working with cross-functional teams.
- Strong written and verbal communication skills, with the ability to influence and drive improvements in supplier performance.
- Familiarity with quality tools and methodologies such as Six Sigma, Lean, FMEA, and root cause analysis.
