Quality Engineer

Job Description

Temp to perm possibility On Site

• Responsible for ensuring that suppliers consistently provide materials, components, and services that meet Client quality, regulatory, and operational requirements.
• This role partners closely with suppliers and cross-functional teams including Procurement, Operations, Manufacturing Engineering, R&D, Quality, and Technical Operations to drive supplier performance, manage supplier-related risks, support product and process improvements, and ensure compliance with applicable regulations and standards.
• 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: (Primary Duties, Roles, and/or Authorities)

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 Client 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, Client 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.)

Knowledge and Skills:

• 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
• Demonstrated ability to identify compliance risks and assess business impact
• Ability to manage complexity and lead critical discussions
• Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
• Strong analytical and problem-solving abilities.
• Ability to assess compliance risks and business impact.
• Excellent project management and organizational skills.
• Ability to manage complexity and influence cross-functional teams.
• Strong verbal and written communication skills.
• Ability to lead critical discussions with suppliers and business leaders.
• Proficient in Microsoft Office applications and quality management systems.

Work Environment: (if applicable)

• May require periodic travel to supplier facilities for audits, assessments, supplier development activities, and project support.
• The role operates in a regulated medical device manufacturing environment and requires adherence to all applicable Client quality, safety, and compliance requirements