What are the responsibilities and job description for the Supplier Quality Engineer position at Intellectt Inc?
Role: Supplier Quality Engineer
Location: Plymouth, MN, 55442
Key Responsibilities:
Supplier Quality Management:
- Perform supplier audits to evaluate quality systems and compliance with ISO 13485 and FDA standards.
- Collaborate with suppliers to address quality issues and drive corrective and preventive actions (CAPA).
- Develop and maintain supplier scorecards and performance metrics.
Compliance and Documentation:
- Ensure supplier documentation meets regulatory and quality requirements.
- Review and approve supplier change requests, protocols, and validations.
- Maintain quality agreements and supplier qualification records.
Process Improvement:
- Lead initiatives to improve supplier manufacturing processes and ensure consistent product quality.
- Participate in root cause analysis for supplier-related nonconformances.
- Develop risk assessments for supplier quality issues and implement mitigation plans.
Collaboration and Communication:
- Act as the primary point of contact for suppliers on quality-related issues.
- Work closely with engineering, manufacturing, and procurement teams to support new product introductions and sustaining projects.
- Provide training and guidance to suppliers on quality and regulatory requirements.
Required Qualifications:
- Bachelor’s degree in Engineering, Quality Management, or a related field.
- 3 years of experience in supplier quality engineering in the medical device industry.
- Strong knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and risk management (ISO 14971).
- Experience with CAPA, root cause analysis, and supplier audits.
- Proficiency in quality tools such as FMEA, SPC, and process capability analysis.
- Excellent communication and problem-solving skills.
