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Quality Assurance Engineer

Atrium Staffing
Sparta, NJ Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/21/2025

Our client, a leader in single-use systems and components for the pharmaceutical and biotech industries, specializes in bottle systems, tube set solutions, mixing and stirring technologies, and innovative transition solutions. They are seeking a Quality Assurance Engineer to join their team.

Salary / Hourly Rate :

70k - 80K DOE

Position Overview :

We are seeking a meticulous and skilled Quality Assurance Engineer to work on the company's quality assurance and compliance initiatives. The candidate will be responsible for ensuring adherence to applicable regulatory requirements, managing quality management systems (QMS), and overseeing various audit programs in the manufacturing plant.

Responsibilities of the Quality Assurance Engineer :

  • Ensure regulatory compliance, manage internal audits, and support Quality Management System (QMS) activities.
  • Host customer and supplier audits, lead corrective actions, and participate in Management Review Board (MRB) meetings.
  • Oversee inspections, including in-process, final QC releases, and first article inspections, while managing equipment calibration and validation programs.
  • Conduct quality assessments, resolve customer complaints, and lead investigation teams for problem-solving initiatives.
  • Monitor cleanroom environments, address microbial failures, and drive continuous improvement and lean projects.

Qualifications of the Quality Assurance Engineer :

  • Minimum of 4 years of experience in quality operations within a manufacturing environment, preferably in ISO environments.
  • Strong understanding of global pharmaceutical and biotechnology product regulations, as well as ISO 9001, ISO 13485, 21 CFR Parts 210 / 211, and Part 820.
  • Minimum of 5-8 years' experience with technical documentation, quality audits, change control, and validation of manufacturing processes or product development.
  • Familiarity with statistical process control (SPC) analysis and continuous improvement tools.
  • Strong interpersonal, customer service, and organizational skills.
  • Proficient in problem-solving, planning, and decision-making.
  • Solid mathematical and computer skills, including experience with ERP systems (e.g., SyteLine, SAP, Oracle).
  • Education Requirements :

  • Bachelor's degree in Sciences or Engineering is required.
  • A minimum of 2 years in a Quality Assurance role is preferred.
  • Certifications in ASQ, Green Belt, Lean, or equivalent are desired.
  • Benefits :

  • Comprehensive and competitive benefit package.
  • Salary : $70,000 - $80,000

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