Process Quality Engineer

Signature IT World Inc; Sanford (ME); On-site; USD 70,000 - 85,000; Full time

Job summary

A leading engineering firm in Sanford, Maine, is looking for a Quality Engineer to bridge between various teams and enhance quality processes. The ideal candidate will have a Bachelor's degree in engineering and at least 2 years of experience in a regulated manufacturing environment. Key responsibilities include supporting the plant's quality systems and overseeing the validation program to ensure compliance with industry standards.

Qualifications

• 2+ years of experience in manufacturing, a quality role or equivalent.
• Strong background in quality systems and validation.
• Experience in a regulated industry (i.e. FDA).

Responsibilities

• Provide daily support to the plant for quality issues and improvements.
• Interface effectively with key business partners to drive results.
• Oversee the validation program, conduct risk analysis.

Skills

Quality systems

Process validation

Regulatory compliance (cGMP, 21 CFR 210 & 211)

SAP

Validation software (KNEAT)

InBatch systems

Education

Bachelor’s degree in chemical / mechanical engineering, Chemistry or related science

Job description

Overview

The Quality Engineer provides a critical link between the Innovation team including Implementation and Support (I&S), Engineering (PD&I), Category Technical Managers, Plant Operations, and Quality.

Qualifications

• Bachelor’s degree in chemical / mechanical engineering, Chemistry or related science/engineering discipline.
• 2+ years of experience in manufacturing, a quality role or equivalent.
• A strong background in quality systems, validation, understanding of cGMP and 21 CFR 210 & 211, and experience in working in a regulated industry (i.e. FDA).
• Working knowledge of SAP, validation software (KNEAT), InBatch systems.

Responsibilities

• Provide daily support to the plant to address quality issues and continuous improvement initiatives by spending time in the production area and participating in the site Standard.
• Interface effectively with key business partners including Operations, Technology, Business Unit, Procurement, and Vendors to drive Company results.
• Process Validation & Control: Oversees the validation program, including C&S, conducts risk analysis, maintains and updates validation master plan, develops validation protocols for PQ, and supports IQ/OQ in conjunction with the engineering team.