Manufacturing quality engineering
$90kTop Prospect Group
Job Title: NPI Quality Engineer Location: Type: Temp-to-Perm
Schedule: Monday–Friday, 7:00/8:00 AM – 4:00/5:00 PM
Start Date: ASAP
We are seeking an NPI Quality Engineer to support design transfer and quality operations within a fast-paced, innovative medical device manufacturing environment. This role plays a critical part in launching new products, ensuring compliance with regulatory standards, and driving continuous improvement across the Quality Management System.
Support New Product Introduction (NPI) activities, ensuring compliance with regulatory and quality standards
Evaluate new products and manufacturing processes for quality, risk, and compliance
Develop and maintain control plans, risk management files, validation protocols, and QMS documentation
Define validation requirements and sampling plans for new and existing processes, equipment, and test methods
Develop inspection procedures and improve process controls to enhance efficiency and quality
Support creation and maintenance of Device Master Records (DMR), Device History Records (DHR), and Risk Management Files
Assist in qualification and validation of new manufacturing equipment
Participate in Material Review Board (MRB) activities and manage nonconformance investigations
Lead continuous improvement initiatives within the Quality Management System
Support internal and external audits (FDA, ISO, customers, and regulatory bodies)
3+ years of experience in medical device manufacturing or other regulated industries (aerospace, defense, etc.)
- Experience with validation processes (IQ/OQ/PQ), MSA, and engineering specifications
- Experience with root cause analysis and CAPA processes
- Strong understanding of tolerance analysis and calibration best practices
- Lean or Six Sigma certification preferred
- Experience with software validation, controlled environments, biocontamination controls, or gamma irradiation is a plus
- Strong organizational, communication, and project management skills
Bachelor’s degree (B.in Engineering or related technical field
Top Prospect Group, now part of HW Staffing Solutions, specializes in connecting skilled engineering and manufacturing professionals with leading organizations in medical device, aerospace, and advanced manufacturing industries. We focus on long-term placements that align quality, reliability, and performance.
Qualified candidates are encouraged to apply immediately.
Vacancy posted 3 hours ago
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