What are the responsibilities and job description for the Supplier Quality Engineer III position at System One?
Title: Supplier Quality Engineer II
Location: Lakewood, CO
Schedule: Hybrid 2-3 days on site
Pay: $107,000 - $133,800 - 7% Bonus
Position Overview:
We are seeking a highly skilled Supplier Quality Engineer with extensive experience in the medical device industry to ensure suppliers meet regulatory and quality standards. This role is integral to developing and managing supplier quality programs, conducting audits, resolving quality issues, and driving continuous improvement to ensure the consistent delivery of high-quality components.
Key Responsibilities:
- Develop and implement supplier quality management programs compliant with industry regulations (e.g., ISO 13485, FDA QSR).
- Conduct supplier audits and assessments, focusing on quality systems, processes, and capabilities.
- Collaborate with suppliers to resolve issues and implement corrective/preventive actions (CAPAs).
- Review and approve documentation such as quality agreements and change notifications.
- Perform risk assessments to mitigate quality and compliance risks.
- Support supplier selection and qualification, ensuring compliance.
- Participate in cross-functional teams for new product development and lifecycle management.
- Monitor supplier performance metrics and communicate improvements to management.
Qualifications:
- Bachelor’s degree in Engineering or a related field (advanced degree preferred).
- 6 years of Supplier Quality Engineering experience, preferably in medical devices.
- Strong understanding of quality management systems, regulatory requirements (FDA, ISO), and industry standards.
- Experience with supplier audits and assessments (e.g., ISO 9001).
- Proven track record in supplier development, qualification, and management.
- Strong problem-solving and root cause analysis skills.
- Effective communicator and collaborator with cross-functional teams.
- Willingness to travel domestically and internationally.
Benefits: The company offers competitive compensation, comprehensive benefits (health, dental, vision), wellness programs, life insurance, disability coverages, 401(k) with matching, and vacation/sick leave, among other employee wellness and recognition programs.
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Salary : $107,000 - $133,800
