Quality Engineer

Job Type

Full-time

Description

The objective of this role is to improve quality within production to meet our customers' needs and expectations. The Quality Engineer will focus on process and equipment improvements, develop quality control systems and processes, and attack quality system failures using effective root cause analysis methods. Additionally, this role will concentrate on continuous improvement through the implementation of effective Corrective and Preventive Actions (CAPA). The Quality Engineer will play a key role in ensuring that products meet industry standards, regulatory requirements, and internal quality objectives, while promoting a culture of compliance and continuous improvement across the organization. The Quality Engineer will lead the process validation, equipment qualification, and cleaning validation activities for the Quality Assurance Department.

Responsibilities :

• Lead quality-related problem-solving and root cause analysis in manufacturing to prevent recurrences.
• Lead process validation, equipment qualification, and cleaning validation activities.
• Participate in the investigation of technical issues, status of testing, and the establishment of procedures and CAPA to ensure product quality and regulatory compliance.
• Operate independently, representing the quality organization in major meetings to resolve key issues and plan work.
• Coordinate cross-functional teams to address Non-Conformance issues to reduce scrap and improve First Pass Yield (FPY).
• Identify and analyze quality problems in production and testing, leading the problem-solving process to root cause determination and evaluating the effectiveness of implemented actions.
• Work with internal teams and customers to identify and develop key quality metrics and ensure systematic analysis of quality data to drive improvements.
• Update and write SOPs validation protocols, conduct internal audits and support Supplier Qualification process.
• Ensure compliance with company policies, procedures, and quality standards, including Good Manufacturing Practices (cGMP), safety, and environmental regulations.
• Participate in safety, GMP, and other company-required training sessions.

Requirements

Requirements :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Key competencies include :

Required Education & Experience :

Preferred Education & Experience :

Salary Description

80k - $100k / yr

Salary : $80,000 - $100,000