Description:
The Supplier Quality Engineer is responsible for ensuring that the quality of materials, components, and services provided by suppliers meets the specifications, regulatory requirements, and company standards. This role involves managing supplier quality, auditing, conducting investigations, implementing corrective and preventive actions (CAPAs), and collaborating with suppliers to improve their quality systems in alignment with industry best practices.
Key Responsibilities:
- Develop, implement, and manage supplier quality programs to ensure that suppliers meet regulatory, quality, and performance requirements.
- Perform supplier quality audits and assessments to evaluate compliance with ISO 13485, FDA regulations, and other applicable standards.
- Review supplier documentation, including Certificates of Compliance (CoC), test reports, and inspection data, to ensure products meet specifications before use in manufacturing.
- Conduct supplier qualification and requalification processes, including approval of new suppliers, on-site audits, and periodic performance evaluations.
- Evaluate suppliers' quality systems, processes, and capabilities to ensure they are capable of providing products that meet quality standards.
- Lead supplier risk assessments and establish action plans to mitigate risks related to supplier performance.
- Investigate supplier-related non-conformances and deviations, and initiate root cause analysis and corrective and preventive actions (CAPA).
- Collaborate with suppliers to develop and implement corrective actions to address quality issues.
- Monitor the effectiveness of CAPA implementation and track improvement actions to completion.
- Ensure that any changes to the supplier's processes, products, or quality systems are properly documented, reviewed, and approved in accordance with change control procedures.
- Maintain accurate records of supplier performance, audits, non-conformance reports (NCRs), and CAPA actions.
- Work closely with internal teams (e.g., R&D, Manufacturing, Regulatory Affairs) to address supplier-related quality issues and ensure continuity of supply.
- Act as the primary point of contact between the company and suppliers for quality-related issues, including performance, quality standards, and regulatory compliance.
- Communicate supplier quality performance metrics to management, including trends, issues, and opportunities for improvement.
- Identify opportunities for continuous improvement in supplier quality systems and processes.
- Work with suppliers to implement best practices for quality management and process optimization.
- Participate in cross-functional teams to support process improvements, product quality, and cost reduction initiatives.
Requirements:
- Education:
- Bachelor’s degree in Engineering, Life Sciences, Quality, or related field.
- Experience:
- 5+ years of experience in Supplier Quality Engineering, Quality Assurance, or a related role within the medical device or highly regulated industry.
- Strong understanding of quality systems (ISO 13485, FDA 21 CFR Part 820) and experience with supplier audits and qualification processes.
- Proven experience in managing supplier quality issues, conducting root cause analysis, and implementing CAPA.
- Skills:
- Strong knowledge of supplier quality management and auditing techniques.
- Proficient in the use of statistical tools for data analysis (e.g., SPC, Minitab).
- Ability to assess supplier performance, understand root causes, and drive improvements.
- Excellent communication skills, both written and verbal, with the ability to interact effectively with suppliers and internal stakeholders.
- Experience with ERP systems and document control software (e.g., SAP, TrackWise, or other QMS tools).