Supplier Quality Engineer | Rancho Cucamonga, CA | Onsite

Title: Supplier Quality Engineer

Location: Rancho Cucamonga, CA | Onsite

Duration: 6+ Month Contract

Essential Functions

• Essential functions include the following. Other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Operational Quality Improvement:

• Support and execute FDA remediation activities associated with Supplier Management and the Quality Management System at the Rancho Cucamonga facility.
• Work closely with Quality, Operations, Engineering, Purchasing, Regulatory, and other cross-functional teams to drive assigned remediation activities to completion.
• Identify gaps within existing supplier controls and historical supplier documentation and implement actions necessary to bring supplier records into compliance with established procedures and applicable regulatory requirements.
• Develop, revise, and implement procedures, work instructions, forms, risk assessments, and other quality-system documentation associated with supplier management and assigned remediation activities.
• Apply risk-based thinking and data analysis to prioritize remediation activities and ensure resources are focused on suppliers and activities presenting the greatest quality or regulatory risk.
• Track assigned remediation actions, deliverables, and due dates and provide routine status updates to Quality Management.
• Support development and collection of objective evidence necessary to demonstrate implementation and effectiveness of remediation activities.

Quality Management System (QMS) Support:

• Follow applicable FDA requirements, ISO 13485, company procedures, and other applicable regulatory and customer requirements.
• Perform comprehensive review and remediation of supplier qualification and monitoring records, including, but not limited to:
  • Supplier Quality System Surveys.
  • ISO certifications and applicable regulatory certifications.
  • Supplier qualification and approval documentation.
  • Supplier risk assessments and classifications.
  • Supplier performance scorecards.
  • Supplier audit history and reports.
  • Supplier corrective actions and quality performance history.
  • Quality agreements and applicable supplier documentation.
• Obtain missing or outdated supplier documentation and work directly with suppliers and internal stakeholders to resolve identified documentation gaps.
• Develop, update, and execute risk-based supplier assessments to support supplier classification, qualification, monitoring, requalification, and audit requirements.
• Develop and maintain supplier performance scorecards using available historical and current quality, delivery, nonconformance, complaint, and corrective-action data.
• Evaluate supplier performance and recommend appropriate actions based on documented risk and performance.
• Identify suppliers requiring additional qualification activities, increased monitoring, corrective action, orsupplier audits.
• Plan, coordinate, conduct, and document supplier audits as required based on supplier risk, performance, or Quality Management System requirements.
• Support Supplier Corrective Action Requests (SCARs), investigations, CAPAs, and other quality-system activities associated with supplier performance.
• Support internal and external audits and provide documentation and objective evidence associated with assigned FDA remediation activities.
• Analyze supplier data and trends to identify systemic risks and opportunities for improvement.
• Support verification of effectiveness activities associated with Supplier Management remediation.
• Perform other quality system and supplier management activities as assigned that are necessary to support the execution, completion, and verification of regulatory remediation commitments, including activities arising from FDA observations, internal gap assessments, CAPAs, audits, or subsequent remediation findings.

Required Education and Experience

• Bachelor's degree in Engineering, Science, Quality, Technology, or related technical discipline; significant applicable experience, training, and professional certifications may be considered.
• Five (5) or more years of experience in Quality Engineering, Supplier Quality Engineering, Quality Systems, or a related regulated manufacturing environment.
• Demonstrated experience with supplier qualification, supplier monitoring, supplier risk assessment, supplier performance management, and/or supplier auditing.
• Experience working within an FDA-regulated and/or ISO 13485 Quality Management System.
• Experience reviewing and remediating Quality System documentation and identifying gaps against procedures and regulatory requirements.
• Experience communicating directly with suppliers and cross functional stakeholders and driving assigned actions to closure.
• Strong technical writing skills with experience developing reports, investigations, procedures, risk assessments, audit documentation, and other Quality System records.
• Ability to analyze historical and current quality data and translate findings into documented risk-based

Preferred Experience

• Medical device manufacturing experience.
• Experience supporting FDA inspection remediation, FDA 483 responses, CAPA remediation, or other significant regulatory remediation activities.
• Supplier Quality Engineering experience within an ISO 13485-certified organization.
• Supplier auditor or ISO 13485 auditor experience.
• Experience developing and implementing supplier scorecards and risk-based supplier monitoring programs.
• Experience with Supplier Corrective Action Requests (SCARs), CAPA, NCR, complaint investigations, and effectiveness verification.
• Experience with Computer System Validation (CSV) and/or Computer Software Assurance (CSA).
• Experience validating software used within manufacturing, inspection, laboratory, or Quality Management System processes.
• Experience developing or executing validation protocols, requirements, risk assessments, test scripts, traceability documentation, and validation reports.
• Experience within injection molding, plastic manufacturing, assembly, or other high-volume regulated manufacturing environments.

Competencies

• Ability to independently manage multiple remediation activities and drive deliverables to completion within established timelines.
• Ability to define problems, collect and analyze data, establish facts, assess risk, and develop technically sound conclusions.
• Strong organizational skills with the ability to review and reconcile large volumes of historical supplier and Quality System documentation.
• Ability to identify documentation and compliance gaps and determine appropriate actions based on risk.
• Ability to effectively conduct supplier assessments and audits and communicate findings professionally to suppliers and internal stakeholders.
• Ability to apply risk-based thinking to supplier qualification, monitoring, corrective action, and Quality System decisions.
• Ability to effectively present information and respond to questions from Quality Management, cross- functional teams, suppliers, customers, and auditors.
• Ability to work independently while escalating significant compliance risks, barriers, and decisions to Quality Management.
• Ability to interpret technical documentation, procedures, specifications, quality records, and applicable regulatory requirements.
• Ability to interact effectively with all levels of the organization.
• Strong working knowledge of FDA-regulated Quality Systems and ISO 13485 requirements.
• Strong computer skills and ability to effectively utilize electronic Quality Systems, ERP systems, spreadsheets, databases, and other applications required to execute remediation activities.

Best regards,

Lavesh Kumar

| Sr. Technical Recruiter

STELLENT IT A Nationally Recognized Minority
Certified Enterprise

Phone: +1 4073580989

Email: lavesh@stellentit.com

Hangouts: lavesh@stellentit.com

LinkedIn: https://www.linkedin.com/in/bhardwajlavesh