Program Manager

Haigh-Farr, Inc; Bedford (NH); On-site; USD 80,000 - 90,000; Full time

Job summary

Top Prospect Group seeks an NPI Quality Engineer to support design transfer and quality operations in a fast-paced medical device environment. You will help launch new products, ensure regulatory compliance, and drive continuous improvement across the QMS.

The role requires 3+ years in medical device manufacturing or regulated industries, with strong knowledge of CFR Part 820 and ISO 13485, and experience in IQ/OQ/PQ validation and CAPA processes. Start ASAP, temp-to-perm, Manchester NH.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Experience with CFR Part 820 and ISO 13485.
• Experience with validation (IQ/OQ/PQ), MSA, and engineering specs.
• Knowledge of Design Transfer and NPI processes.
• Experience with root cause analysis and CAPA processes.
• Lean or Six Sigma certification preferred.

Responsibilities

• Support NPI activities ensuring regulatory and quality standards.
• Evaluate new products and processes for quality and risk.
• Develop and maintain control plans, risk files, validation protocols, and QMS docs.
• Lead validation efforts including IQ/OQ/PQ and reporting.
• Conduct CAPA investigations and implement corrective actions.
• Define validation requirements and sampling plans.
• Develop inspection procedures and improve process controls.
• Assist in DMR/DHR and risk management files.
• Participate in MRB and nonconformance investigations.
• Lead continuous improvement within QMS and support audits.

Skills

Regulatory compliance

Quality systems knowledge

Root cause analysis

Project management

Risk management

Documentation

CAPA

Lean/Six Sigma

Validation concepts

Design Transfer

Education

Bachelor’s degree in Engineering

Tools

IQ/OQ/PQ validation

MS Excel

Job description

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