NPI Quality Engineer/Quality Engineer
Job in
Manchester, Hillsborough County, New Hampshire, 03103, USA
Listed on 2026-07-13
Listing for:
Top Prospect Group LLC
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist, Process Engineer
Job Description & How to Apply Below
Job Title: NPI Quality Engineer / Quality Engineer
Location: Manchester, NH
Type: Temp-to-Perm
Salary: $80,000 – $90,000 (Based on Experience)
Schedule: Monday–Friday, 7:00/8:00 AM – 4:00/5:00 PM
Start Date: ASAP
POSITION OVERVIEWWe 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.
ESSENTIAL DUTIES & RESPONSIBILITIES- 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
- Lead validation efforts including IQ/OQ/PQ protocol development, execution, and reporting
- Conduct root cause investigations and implement corrective and preventive actions (CAPA)
- 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.)
- Strong knowledge of CFR Part 820 and ISO 13485
- Experience with validation processes (IQ/OQ/PQ), MSA, and engineering specifications
- Knowledge of Design Transfer and new product introduction processes
- 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.S. or B.A.) in Engineering or related technical field
- Equivalent experience will be considered
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