Supplier Quality Engineer

Position 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 provide 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, and helping 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.

Job Responsibilities

• Responsible for the appropriate qualification and on-going monitoring of Caris’ suppliers.

• Own Supplier related CAPA review and management, ensuring effective use of appropriate problem-solving tools.

• Perform critical assessment of internal and supplier proposed change management activities.

• Support tracking and reporting of KPI and other metrics associated with supplier performance.

• Provide education and training to suppliers as necessary.

• Articulate detailed supplier performance results and trends to appropriate levels of management.

• Perform detailed process reviews at supplier's manufacturing site.

• Assess and critique supplier process control documentation, identifying areas of improvement and driving improvement within the suppliers QMS.

• Maintain and track to completion closure of assigned supplier action items.

• Collaborate with internal teams and stakeholders to prioritize supplier-initiated change requests.

• Develop relationships with suppliers and internal cross functional partners

• Manage supplier-initiated changes for continuous improvement, cost reduction or supplier remediation activities.

• Analyze non-conformance data to prioritize projects and to solve systemic supplier issues.

• Transfer “lessons learned” from the supply base back to Product Development for incorporation into next generation designs.

• Provide problem solving expertise at site and supplier locations in support of critical quality issues.

• Train, mentor, and assist in the development of less experienced engineers.

• Propose and develop effective quality improvement plans to be implemented at appropriate suppliers.

• Engage and interface in internal and external audits providing subject matter expertise.

• Assist, as needed, to perform other related duties and special projects as required.

Required Qualifications

• Bachelor’s degree in engineering, sciences or similar field required.

• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

• Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

Preferred Qualifications

• A minimum of 3 years of experience working within FDA regulated (Medical Device) or regulated industries (Automotive, Aerospace) highly preferred.

• Internal Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements.)

• Basic knowledge of FMEA, validation programs and SPC processes.

• Basic understanding of manufacturing prints, specifications and tolerance.

• Demonstrated organizational, interpersonal, oral and written skills.

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.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.