Process Quality Engineer

Description

Position Summary:

The objective of this role is to improve quality within production to meet our customers’ needs and expectations. The Process Quality Engineer will focus on process and equipment improvements, develop bi-lingual manufacturing records, 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 Process 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 Process Quality Engineer will lead the process manufacturing record development, assist with equipment qualification, and training of employees on manufacturing processes and procedures.  

Key Responsibilities:

• Lead the development of Bell manufacturing and packaging records. 
• Assist in quality-related problem-solving and root cause analysis in manufacturing to prevent recurrences.
• Assist in execution of 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.
• 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.
• Update and write bi-lingual SOPs validation protocols, conduct internal audits. 
• 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

Required Skills/Abilities:

• Strong knowledge of quality assurance methods, tools, and relevant manufacturing processes.
• Experience with quality management software and systems (e.g., CAPA, FMEA, Statistical Process Controls).
• Experience developing and writing manufacturing and packaging batch records, validation and qualification protocols.
• Excellent analytical, critical thinking, and problem-solving skills.
• High ethical standards, integrity, and professional behavior.
• Excellent communication, problem-solving, and organizational skills. Ability to work independently and collaboratively within a fast-paced, cross-functional environment. 
• Strong proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Ability to multitask and adapt to a flexible schedule.

Required Education and Experience:

• Bachelor’s degree in Engineering.
• 3-5 years of experience in pharmaceuticals or cosmetics.
• Strong knowledge of quality systems (GMP, FDA, ISO 9001, regulations), personal care and cosmetic industry standards, and regulatory compliance.

Preferred Education and Experience:

• Master’s degree in Engineering or related field preferred.
• Bi-lingual (English/Spanish).
• ASQ Certified Quality Engineer (CQE) certification is a plus.