Quality Engineer

Our client is seeking a Quality Engineer at our manufacturing site in Philadelphia, PA. The Quality Engineer is responsible for ensuring that products, processes, and systems comply with internal quality standards as well as customer, regulatory, and industry requirements. This role works closely with Quality Control and Manufacturing teams to drive continuous improvement, minimize defects, and resolve quality issues through structured, data-driven problem-solving approaches.

Responsibilities to include,

• Develop, implement, and maintain quality systems, tools, and procedures to support product and process quality objectives.
• Lead root cause analysis and corrective and preventive action (CAPA) activities related to nonconformances, customer complaints, and internal findings.
• Support New Product Introduction (NPI) activities, including risk assessments (FMEA), control plan development, and validation efforts.
• Conduct and support internal, supplier, and customer audits to ensure compliance with applicable quality standards and regulatory requirements.
• Collect, analyze, and interpret quality data and metrics to identify trends, risks, and opportunities for improvement.
• Collaborate with cross-functional teams to drive continuous improvement initiatives using Lean, Six Sigma, or related methodologies.
• Review and approve engineering changes, specifications, and work instructions from a quality perspective.
• Provide quality guidance and support to manufacturing operations, suppliers, and external partners.
• Ensure effective document control and adherence to electronic Quality Management System (eQMS) requirements.

Minimum REQUIRED Qualifications:

• Bachelor’s degree in Chemical Engineering, Chemistry, Engineering, or a related technical discipline + 2 years of experience in quality engineering or a related role; client may consider candidates without a relevant degree + 5 years of experience in quality engineering
• Experience working within a Quality Management System (e.g., ISO 9001)
• Proficiency with data analysis and reporting tools such as Microsoft Excel, statistical software, or quality systems
• Ability to reliably work onsite in Philadelphia, PA 19134. Shifts: 7a-4p and 10a-7p. Prioritizing candidates who are available/flexible to work both shifts.
• Immigration sponsorship is not available for this role.

Preferred Qualifications:

• Strong working knowledge of quality tools and methodologies, including FMEA, SPC, MSA, Control Plans, and Root Cause Analysis techniques (e.g., 5 Whys, Fishbone)
• Working knowledge of SAP Six Sigma Green Belt or Black Belt certification, or Lead Auditor certification
• Experience in regulated industries such as medical devices, automotive, aerospace, or pharmaceuticals
• Familiarity with risk management and process or product validation activities
• Strong analytical and problem-solving skills
• Excellent written and verbal communication abilities
• Ability to collaborate across functions and influence outcomes without direct authority
• Detail-oriented mindset with a strong focus on quality and continuous improvement