Supplier Quality Engineer

The SQE will lead supplier quality initiatives, supplier qualification activities, investigations, corrective actions, audits, and risk management efforts to support business continuity and product quality.

Job Responsibilities:
Supplier Quality Management
Collaborate with suppliers and internal business partners to ensure robust materials, products, processes, and quality systems.
Manage supplier quality performance through data analysis, trend monitoring, and risk assessment activities.
Identify supplier quality risks and drive mitigation plans to minimize business disruptions.
Develop and maintain Supplier Quality Agreements in collaboration with suppliers and Supplier Quality leadership.
Lead supplier performance improvement initiatives and supplier development activities.
Supplier Audits and Compliance
Plan, execute, document, and follow up on supplier quality system audits.
Evaluate supplier compliance with FDA regulations, ISO standards, and BD Quality System requirements.
Assess supplier quality systems and manufacturing controls to ensure continued compliance.
Support supplier qualification and requalification activities.
Investigations and Corrective Actions
Lead and support supplier-related root cause investigations.
Drive supplier Corrective and Preventive Actions (CAPA) and Supplier Corrective Action Requests (SCARs).
Ensure effective implementation and verification of corrective actions.
Escalate critical supplier quality issues when intervention is required.
Change Management
Manage supplier change notifications and change control activities.
Coordinate impact assessments for supplier and material changes.
Support supplier transitions, component qualifications, and validation activities.
Partner with cross-functional teams to ensure timely approval and implementation of changes.
Continuous Improvement
Lead supplier quality improvement projects with minimal supervision.
Apply Lean, Six Sigma, and Performance Excellence tools to improve supplier performance and process capability.
Utilize methodologies such as: DMAIC, Kaizen, Value Stream Mapping (VSM), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis (RCA), Measurement System Analysis (MSA), Statistical Process Control (SPC), Capability Analysis (Cp/Cpk/Ppk), Design of Experiments (DOE)
Cross-Functional Collaboration
Partner with Procurement, Manufacturing, Operations, Engineering, Technical Operations, and R&D teams to investigate and resolve supplier-related quality issues.
Support new product introduction (NPI) and component qualification projects.
Participate in risk management and product improvement efforts.
Communicate supplier quality issues, trends, and opportunities to management.
Quality and Regulatory Compliance
Ensure compliance with: FDA 21 CFR Part 820, ISO 13485, ISO 14971, BD Quality System Requirements, Environmental, Health & Safety policies
Support FDA inspections and external regulatory audits.
Maintain accurate documentation in accordance with ALCOA+ principles and good documentation practices.

Education and Experience:
Bachelor's degree in Engineering or related field.
5 years Supplier Quality and/or Supplier Development 
Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements 
Prior Supplier Quality experience in a manufacturing plant or technical background 
Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.)
Bilingual professional with strong verbal and written communication skills in both English and Spanish.
Demonstrated knowledge of manufacturing principles and practices, and procedures 
Direct experience in plant and/or supplier GMP auditing 
Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA/SCAR systems and investigations, production and process controls 
Experience with documentation and technical writing skills, in a regulated compliance environment