Quality/Validation Engineer Position Available In Cumberland, Maine
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Job Description
Description We are seeking a highly motivated and detail-oriented Validation/Quality Engineer to support our manufacturing operations. This role is critical in ensuring compliance with FDA regulations (21 CFR Part 820) and
ISO 13485
standards. The ideal candidate will lead validation activities, maintain robust quality systems, and drive continuous improvement initiatives across manufacturing processes.
Key Responsibilities:
Validation & Qualification:
Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and systems. Lead risk assessments and validation strategy development in alignment with regulatory requirements. Maintain validation master plans and ensure timely revalidation.
Quality Systems & Compliance:
Support and maintain quality systems including CAPA, nonconformance, change control, and document control. Ensure compliance with FDA, ISO, and internal quality standards. Participate in internal and external audits, including FDA inspections.
Documentation & Reporting:
Prepare and review technical documentation including validation reports, SOPs, and work instructions. Ensure accurate and timely documentation in accordance with Good Documentation Practices (GDP).
Cross-Functional Collaboration:
Work closely with manufacturing, engineering, regulatory, and quality assurance teams. Provide training and guidance on validation and quality system requirements.
Continuous Improvement:
Identify and implement process improvements to enhance product quality and operational efficiency. Utilize tools such as Six Sigma, Root Cause Analysis, and FMEA.
Qualifications :
MUST come from a Life Sciences Manufacturing (GMP) background 5-10 years of Validation related experience.
