Quality Engineer II

The Fountain Group; Branchburg Township (NJ); On-site; USD 96,000 - 141,000; Full time

Job summary

The Fountain Group is seeking qualified Quality Engineers at theQE and Senior QE levels for a Branchburg, NJ site. This role emphasizes Manufacturing Quality Assurance in a regulated environment and collaboration with cross-functional teams to ensure regulatory and internal standards are met.

Ideal candidates will bring strong experience with Quality Systems, risk management, investigations, CAPA, and FMEA, with opportunities for leadership on complex projects and on-call support as needed.

Qualifications

• Bachelor's degree in engineering, biology, chemistry or related discipline.
• 2+ years of experience in manufacturing, quality, engineering or related regulated environment.
• Knowledge of deviations, investigations, CAPA, root cause analysis, and risk management.
• Experience with Quality Systems and regulatory compliance.

Responsibilities

• Provide Manufacturing Quality Assurance support for ongoing manufacturing operations and quality-related projects.
• Ensure manufacturing practices and procedures comply with regulations, quality standards, and company policies.
• Lead and/or support investigations of manufacturing events, deviations, and nonconformances with thorough documentation.
• Support CAPA, root cause analysis, product impact assessments, and risk management activities.
• Apply risk management principles and tools, including FMEA, to identify and mitigate risks.
• Review and approve SOPs ensuring compliance with Quality and Regulatory requirements.
• Collaborate cross-functionally to resolve technical and quality issues.
• Support equipment qualification, validation, calibration, and process improvement activities.
• Assist with the implementation and effectiveness of the Quality Management System.
• Support continuous improvement initiatives to enhance quality and process performance.

Skills

Engineering

Biology/Chemistry

Deviations

CAPA

FMEA

Quality Systems

Root Cause Analysis

Risk Management

Education

Bachelor's degree in Engineering, Biology or Chemistry

Job description

The Fountain Group. We are a national staffing firm and are currentlyseeking a Quality Engineer / Sr. Quality Engineerfor a prominent clientofours. This position is in Branchburg, NJ08876 Details for the positionare as follows:

Quality Engineer / Senior Quality Engineer

Location:Branchburg, NJ
Schedule:100% Onsite
Quality Engineer Pay:$46–$49/hr
Senior Quality Engineer Pay:$63–$68/hr
Schedule:Monday–Friday, 8:00 AM–5:00 PM, with rotating weekly on-call coverage for evenings and weekends

Position Overview

We are seeking Quality Engineers at both the Quality Engineer and Senior Quality Engineer levelsto support Manufacturing Quality Assurance activities within a regulated manufacturing environment.

These positions 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.

Candidates should have strong experience with Quality Systems, manufacturing quality, risk management, investigations, root cause analysis, and regulatory compliance. Level and compensation will be determined based on relevant experience and technical depth.

Key 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.
• SupportCAPA, root cause analysis, product impact assessments, and risk management activities.
• Apply risk management principles and tools, includingFMEA, 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

Senior-level candidates will provide increased technical leadership and Quality oversight, including:

• Provide Quality oversight for projects involvingnew 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 ofqualification 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.
• Supportdata integrity initiativesto 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.

Required Qualifications

Quality Engineer

• Bachelor's degree, preferably inEngineering, Biology, Chemistry, or a related scientific discipline, or equivalent related experience.
• 2+ years of experiencewithin Manufacturing, Quality, Engineering, or a related regulated environment.
• Experience with manufacturing Quality Systems and regulatory compliance.
• Understanding ofdeviations, investigations, CAPA, root cause analysis, and risk management.
• Knowledge ofFMEAand 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 inEngineering, Biology, Chemistry, or a related scientific discipline.
• 6+ years of experiencewithin 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 withequipment 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.

Key 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 environmentsis highly desirable.