Supplier Quality Engineer

Role Summary

The Supplier Quality Engineer is primarily responsible for ensuring the needs of internal customers are met by Caris’ suppliers, working to address quality issues and providing technical support related to the quality system assessment and performance evaluation. This role applies a risk-based approach to supplier monitoring, qualification and assessment, working closely with functional groups help drive corrective action when necessary. The Supplier Quality Engineer acts as a liaison between Caris and its suppliers to ensure product quality and continuous improvement.

Responsibilities

• Responsible for the appropriate qualification and on-going monitoring of Caris‚Äô suppliers
• Assist in performing supplier audits providing subject matter expertise. Can lead supplier audits based on auditor qualifications.
• Assess and critique supplier process control documentation, identifying areas of improvement and driving improvement within the suppliers‚Äô QMS.
• Open and assist with Supplier Corrective Action Request, ensuring effective use of appropriate problem-solving tools.
• Performs critical assessment of internal and supplier proposed change management activities.
• Provide education and training to suppliers as necessary.
• Provide problem solving expertise at site and supplier locations in support of critical quality issues.
• Assist with development of effective quality improvement plans to be implemented at appropriate suppliers.
• Collaborate with internal teams to gather assessments for supplier-initiated changes requests for continuous improvement, cost reduction or supplier remediation activities.
• Support tracking and reporting of KPI and other metrics associated with supplier performance.
• Articulate detailed supplier performance results and trends to appropriate levels of management.
• Perform detailed process reviews at supplier's manufacturing site.
• Maintain and track to completion closure of assigned supplier action items.
• Develop relationships with suppliers and internal cross functional partners
• Analyze non-conformance data to prioritize projects and to solve systemic supplier issues
• Assist, as needed, to perform other related duties and special projects as required

Qualifications

• Required: Bachelor's degree in engineering
• Required: Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)
• Required: Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use
• Preferred: A minimum of 3 years of experience working within FDA regulated (Medical Device) or regulated industries (Automotive, Aerospace) highly preferred
• Preferred: Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements)

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.