Quality Engineer II

The Fountain Group is seeking Quality Engineers at both the Quality Engineer and Senior Quality Engineer levels for a prominent client in Branchburg, NJ (08876). This is a 100% onsite role.

Pay

• Quality Engineer: $46–$49/hr
• Senior Quality Engineer: $63–$68/hr

Schedule

• Monday–Friday, 8:00 AM–5:00 PM
• Rotating weekly on-call coverage for evenings and weekends

About the Role

These positions will support Manufacturing Quality Assurance activities within a regulated manufacturing environment. Candidates will partner closely with Manufacturing, Engineering, Validation, Quality, and other cross-functional teams to ensure manufacturing processes, equipment, systems, investigations, and quality activities meet applicable regulatory requirements and internal quality standards. Level and compensation will be determined based on relevant experience and technical depth.

Responsibilities

• Provide Manufacturing Quality Assurance support for ongoing manufacturing operations and quality-related projects.
• Ensure manufacturing practices and procedures comply with applicable regulations, quality standards, and company policies.
• Lead and/or support investigations of manufacturing events, deviations, and nonconformances, ensuring investigations are thorough, accurate, and appropriately documented.
• Support CAPA, root cause analysis, product impact assessments, and risk management activities.
• Apply risk management principles and tools, including FMEA, to identify and mitigate product and process risks.
• Review and approve Standard Operating Procedures (SOPs), ensuring procedures meet applicable Quality and Regulatory requirements.
• Partner cross-functionally with Manufacturing, Engineering, Validation, Quality, and other plant departments to resolve technical and quality issues.
• Support equipment qualification, validation, calibration, and process improvement activities.
• Assist with the implementation and continued effectiveness of the Quality Management System.
• Support continuous improvement initiatives designed to improve manufacturing quality, compliance, and process performance.

Additional Senior Quality Engineer Responsibilities

• Provide Quality oversight for projects involving new equipment, software/computer systems, automation systems, new products, technologies, and manufacturing process improvements.
• Lead Quality and Compliance activities associated with project execution.
• Provide Quality oversight of qualification and validation strategies, protocols, commissioning activities, and validation documentation.
• Audit and review commissioning, qualification, and validation documentation completed by cross-functional teams.
• Author and/or execute qualification and validation protocols when required.
• Support data integrity initiatives to ensure the security, accuracy, consistency, and completeness of regulated data.
• Support Risk Management activities across applicable Quality System elements.
• Review and approve critical planned maintenance activities from a Quality perspective.
• Provide technical guidance and Quality decision-making support for complex manufacturing deviations, investigations, and compliance issues.
• Provide remote off-shift Quality support as required through a rotating on-call schedule.

Requirements

Quality Engineer

• Bachelor's degree, preferably in Engineering, Biology, Chemistry, or a related scientific discipline, or equivalent related experience.
• 2+ years of experience within Manufacturing, Quality, Engineering, or a related regulated environment.
• Experience with manufacturing Quality Systems and regulatory compliance.
• Understanding of deviations, investigations, CAPA, root cause analysis, and risk management.
• Knowledge of FMEA and risk-based quality principles.
• Strong analytical and technical problem-solving skills.
• Strong written and verbal communication skills.
• Ability to work effectively with cross-functional teams.

Senior Quality Engineer

• Bachelor's degree, preferably in Engineering, Biology, Chemistry, or a related scientific discipline.
• 6+ years of experience within Manufacturing, Quality, Engineering, or a related regulated environment.
• Demonstrated experience implementing and maintaining effective Quality Systems.
• Strong experience supporting manufacturing operations and resolving complex Quality issues.
• Experience with equipment qualification, validation, computer systems, software and/or automation systems.
• Strong knowledge of deviation investigations, CAPA, root cause analysis, risk management, and Quality documentation.
• Ability to provide Quality leadership and influence cross-functional project teams.

Skills

• Quality Systems & Regulatory Compliance: ISO 13485, ISO 14971, FDA 21 CFR Part 820/QMSR, cGMP, Quality Management Systems
• Quality Engineering: CAPA, Deviations, Investigations, Root Cause Analysis, Product Impact Assessments, Risk Management, FMEA, SOPs
• Manufacturing Quality: Manufacturing Quality Assurance, Process Quality, Quality Oversight, Calibration, Validation, Qualification, Continuous Improvement
• Senior-Level Technical Areas: Equipment Qualification, Validation Strategy, Computer System Validation, Automation Systems, Data Integrity, Commissioning & Qualification

Preferred Experience

Experience within pharmaceutical, biotechnology, medical device, API, bulk drug, finished drug, or other highly regulated manufacturing environments is highly desirable.