Senior NPI Quality Assurance Engineer – Medical Devices
Picture your day beginning on the manufacturing floor of a regulated medical device contract manufacturer. You greet the NPI project manager to review the latest build, pull up process capability charts, and walk through a recent FAI while lining up the next validation run. By afternoon, you’re facilitating a PFMEA with a cross-functional team, closing out audit findings, and mentoring a Quality Engineer II on constructing a data-driven control plan. Before you log off, you capture lessons learned and recommend quality improvements that scale across the organization.
What you’ll own
- Serve as the Quality Engineering partner for New Product Introduction projects in a customer-facing role, supporting manufacturing from prototype through release.
- Analyze data statistically to evaluate process capability (Cpk/Ppk), review first article acceptance (FAI) outcomes, and interpret visual inspection results.
- Author clear, decision-driving validation reports that summarize validation runs and trigger corrective actions where appropriate.
- Define and maintain inspection requirements; facilitate PFMEAs; resolve discrepant material; and build quality documents such as control plans and inspection plans.
- Act as the quality interface for NPI teams responding to customer complaints through failure analysis, development of corrective and preventive actions (CAPA), and trend analysis.
- Plan and conduct audits, document findings, close gaps, and determine robust corrective and preventative actions.
- Coach and mentor Quality Engineers I, II, and III; share best practices as a subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge).
- Lead and participate in large, company-wide initiatives, offering quality recommendations that enhance compliance and performance.
Impact you’ll make
In this role, you will define, implement, and continuously improve quality practices to ensure compliance with industry standards and regulatory requirements. Your guidance will strengthen manufacturing quality assurance and enable business growth by accelerating high-quality product introductions.
What you bring
- Bachelor’s degree in Mechanical, Industrial, or another Engineering or Physical Science.
- Strong knowledge of quality systems, regulatory requirements, and relevant industry standards for medical devices.
- Proven ability to consistently deliver near-term wins and long-term business results.
- Demonstrated leadership skills, including mentoring and cross-functional influence.
- Hands-on experience with ERP and quality systems.
This position thrives in a fast-paced, regulated environment where rigorous methods, structured problem-solving, and crisp communication with customers and internal teams are essential.