Quality Engineer II

The Fountain Group. We are a national staffing firm and are currently seeking a Quality Engineer / Sr. Quality Engineer
for a prominent clientofours. This position is in Branchburg, NJ
08876 Details for the position are as follows:

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

We are seeking Quality Engineers at both the Quality Engineer and Senior Quality Engineer levels
to 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.

• 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.

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

• 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.

• 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…