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 OVERVIEW
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.
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)
QUALIFICATIONS
- 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
EDUCATION REQUIREMENTS
- Bachelor’s degree (B.S. or B.A.) in Engineering or related technical field
- Equivalent experience will be considered
COMPANY OVERVIEW
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.
HOW TO APPLY
Qualified candidates are encouraged to apply immediately.
Please submit:
- A clean, updated resume
- Salary expectations
- Any available references
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