Quality Process Engineer - Injection Molding & Validation

Merck & Co.; Torrington (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

Merck & Co. is seeking a Process Engineer - Quality Focus to develop, validate, and improve manufacturing processes with emphasis on process capability, product quality, and long-term robustness in a regulated medical device environment.

You will own injection molding and secondary manufacturing processes, collaborate with Quality, Production, Tooling, and Engineering, lead validations (IQ/OQ/PQ), and drive continuous improvement using SPC, pFMEA, and Control Plans to ensure compliant, capable,

Qualifications

• Bachelor's degree in Mechanical Engineering (or related discipline) required.
• 3-7 years of experience in manufacturing/process engineering roles.
• Experience in plastic injection molding and regulated manufacturing environments preferred.
• Strong knowledge of SPC, pFMEA, Control Plans, and process validation.
• Familiarity with ISO 13485 and FDA QSR is a plus.

Responsibilities

• Develop, establish, optimize, and maintain robust manufacturing processes for plastic injection molding and secondary operations.
• Own assigned production cells, define validated process windows and parameter controls.
• Lead process validations (IQ/OQ/PQ) and maintain supporting documentation.
• Partner with Quality, Production, Tooling, Maintenance, and Engineering to ensure compliance and continuous improvement.
• Support NPIs and design transfer through production launch and early process capability.

Skills

Injection molding

SPC

pFMEA

Control Plans

Root cause analysis

Lean manufacturing

ISO 13485 knowledge

Microsoft Office

Education

Bachelor's degree in Mechanical Engineering

Tools

Microsoft Office

Job description

Merck & Co. is seeking a Process Engineer - Quality Focus to develop, validate, and improve manufacturing processes with emphasis on process capability, product quality, and long-term robustness in a regulated medical device environment.

You will own injection molding and secondary manufacturing processes, collaborate with Quality, Production, Tooling, and Engineering, lead validations (IQ/OQ/PQ), and drive continuous improvement using SPC, pFMEA, and Control Plans to ensure compliant, capable,