Quality Engineer
Actalent
Quality Engineer
We are seeking a detail-oriented and experienced Quality Engineer to lead and support quality assurance initiatives within a manufacturing environment. This role is responsible for planning and implementing quality compliance programs, conducting root cause analyses, and ensuring adherence to industry standards and regulatory requirements. The ideal candidate will have experience in validation, process control, and medical device manufacturing.
Key Responsibilities
- Plan, direct, and coordinate quality compliance programs to meet company standards.
- Prepare and implement quality processes and procedures across production operations.
- Conduct root cause analyses and generate non-conformance reports.
- Develop and execute validation protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Utilize metrology and process control techniques to maintain product quality.
- Participate in Material Review Board (MRB) activities to assess and resolve quality issues.
Required Qualifications
- 3 to 5 years of experience in a manufacturing environment.
- Proven experience in quality engineering and working with ISO standards.
- Proficiency in validation processes and process control methodologies.
- Medical device manufacturing.
Preferred Skills
- Bachelor of Science in Manufacturing Engineering or a related discipline.
- Knowledge of disposable medical devices, particularly wire-based products.
- Strong documentation and analytical skills.
- Ability to work collaboratively across engineering, production, and quality teams.
Pay and Benefits
The pay range for this position is $95000.00 - $100000.00/yr.
Medical, dental, vision, Life insurance, long term disability, flexible spending account
Workplace Type
This is a fully onsite position in Rahway, NJ.
Application Deadline
This position is anticipated to close on October 10, 2025.