JOB TYPE: Direct Hire
LOCATION: Sparta, NJ
REMOTE / ONSITE: Onsite
POSTED: Jan 17, 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:
Position Overview:
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.
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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO
