NPI Quality Engineer III

About the Role

We are seeking an experienced NPI Quality Engineer III to join a dynamic manufacturing environment, supporting the successful introduction of new products while ensuring the highest standards of quality, compliance, and continuous improvement.

This role is ideal for a quality engineering professional with a strong background in New Product Introduction (NPI), validation, process improvement, and regulated manufacturing. You will work cross-functionally to deliver robust quality solutions throughout the product development lifecycle.

Key Responsibilities

New Product Introduction (NPI)

• Support all quality activities associated with new product introduction projects.

• Ensure compliance throughout the Product Development Process (PDP).

• Lead and support cross-functional project teams, providing quality expertise.

• Participate in regulatory inspections, customer audits, and quality investigations.

• Support risk management activities in accordance with ISO 14971.

• Assist with product transfers and new process implementation.

• Lead continuous improvement initiatives to enhance product and process quality.

Test Method Development & Validation

• Develop, validate, and implement new test methods, tooling, fixtures, and templates.

• Execute validation protocols, including Gauge R&R studies and statistical analysis using Minitab.

• Generate and approve validation documentation, reports, and procedures.

• Develop incoming, in-process, and final inspection procedures.

• Collaborate with Manufacturing Engineering on process validation and capability studies.

Quality & Compliance

• Investigate quality issues using structured root cause analysis methodologies.

• Support CAPA investigations and ensure timely completion of corrective actions.

• Manage non-conforming material processes and ensure effective disposition.

• Analyse quality data and trends relating to complaints, supplier quality, and manufacturing performance.

• Support internal quality audits and maintain compliance with quality management systems and regulatory requirements.

Continuous Improvement

• Drive process improvements using Lean, Six Sigma, and statistical methodologies.

• Promote standardisation, visual management, workplace organisation, and best practices.

• Support initiatives focused on operational excellence, process optimisation, and quality performance.

What We’re Looking For

Essential Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.

• Minimum of 5 years’ experience in engineering or quality engineering within a regulated manufacturing environment.

• Candidates with significant relevant industry experience may also be considered.

Technical Experience

• Experience supporting New Product Introduction (NPI) projects.

• Strong understanding of process validation, test method validation, and quality systems.

• Proven experience conducting statistical analysis using Minitab.

• Knowledge of CAPA, root cause analysis, non-conformance management, and continuous improvement methodologies.

• Familiarity with ISO standards and regulated manufacturing environments.

• Proficient in Microsoft Office applications.

Desirable

• Six Sigma Green Belt (Black Belt advantageous).

• Experience with project management and structured problem-solving methodologies.

• Knowledge of international quality and regulatory standards.

Skills & Attributes

• Strong analytical and problem-solving skills.

• Excellent communication and stakeholder management abilities.

• Ability to lead technical projects and collaborate across multidisciplinary teams.

• Highly organised with excellent attention to detail.

• Positive, proactive approach with a continuous improvement mindset.

• Comfortable working in a fast-paced manufacturing environment.

Why Apply?

• Opportunity to work on innovative new product development projects.

• Be part of a collaborative, quality-focused engineering team.

• Contribute to continuous improvement and operational excellence initiatives.

• Excellent opportunity for professional development within a highly regulated manufacturing environment.

#: For immediate consideration, please contact Danielle at danielle@hartleypeople.com or call 051-878813.

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