NPI Quality Engineer - Process Controls & MSA

Katalyst-Healthcares-; Tampa (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Tampa, FL is seeking an experienced Quality Engineer to support New Product Introduction (NPI) and manufacturing activities within a regulated environment.

You will collaborate with Manufacturing, Engineering and Operations to ensure products and processes meet quality and customer requirements, develop inspection plans, and drive robust measurement and control strategies on the manufacturing floor.

Qualifications

• Experience in an NPI environment.
• Ability to interpret GD&T and engineering drawings.
• Develop and execute inspection plans and quality protocols.
• Strong knowledge of statistical quality tools, MSA/Gage R&R, PFMEA, IQ/OQ/PQ.

Responsibilities

• Developing and maintaining inspection plans, reviewing and interpreting engineering drawings and specifications, creating and executing quality protocols, and supporting IQ/OQ/PQ activities.
• MSA and Gage R&R studies, inspection methods, control plans, and ensuring appropriate measurement techniques for new and existing processes.
• Leading PFMEA, control plans, process documentation, and inspection plans for quality risk management and continuous improvement.
• Partnering with Manufacturing and Engineering to translate drawings and product requirements into effective inspection and manufacturing controls, identifying quality risks, and supporting root cause analysis and corrective actions.
• Experience in NPI, interpreting GD&T, and implementing quality controls on the manufacturing floor is highly preferred.

Skills

NPI experience

Quality engineering

GD&T interpretation

MSA/Gage R&R

PFMEA

IQ/OQ/PQ

Continuous improvement

Root cause analysis

Job description

Summary:
Our client is seeking an experienced Quality Engineer to support New Product Introduction (NPI) and manufacturing activities within a regulated manufacturing environment.
This individual will work closely with Manufacturing, Engineering, and Operations to ensure products and processes meet quality and customer requirements.
Responsibilities:

• Developing and maintaining inspection plans, reviewing and interpreting engineering drawings and specifications, creating and executing quality protocols, and supporting IQ/OQ/PQ activities.
• The Quality Engineer will also be responsible for measurement system analysis (MSA), Gage R&R studies, inspection methods, control plans/control blocks, and ensuring appropriate measurement and inspection techniques are established for new and existing processes.
• The Quality Engineer will play an active role in process risk management and continuous improvement, including development and review of PFMEAs, control plans, process documentation, and inspection plans.
• The role will involve partnering with Manufacturing and Engineering to translate drawings and product requirements into effective inspection and manufacturing controls, identifying potential quality risks, and supporting root cause analysis and corrective actions.
• Experience working within an NPI environment, interpreting GD&T and engineering drawings, developing inspection protocols, and implementing quality controls on the manufacturing floor is highly preferred.
• Strong knowledge of statistical quality tools, MSA/Gage R&R, PFMEA, IQ/OQ/PQ, and general manufacturing quality processes is required.