Job Type
Full-time
Description
The objective of this role is to improve quality within production to meet our customer's 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.
Responsibilities:
- Lead quality-related problem-solving and root cause analysis in manufacturing to prevent recurrences.
- Participate in the investigation of technical issues, status of testing, and the establishment of procedures and CAPA to ensure product quality and regulatory compliance.
- Conduct supplier and construction surveys, audits, and inspections to verify system and product conformance to quality requirements.
- Operate independently, representing the quality organization in major meetings to resolve key issues and plan work.
- Coordinate cross-functional teams to address Out of Specifications, Deviations, CAPAs, and Change Controls.
- Identify and analyze quality problems in production and QC Laboratory, and Analytical Laboratory testing, leading the problem-solving process to root cause determination and evaluating the effectiveness of implemented actions.
- Work with internal teams to identify and develop key quality metrics and ensure systematic analysis of quality data to drive improvements.
- Update and write SOPs, conduct internal audits, and assist the Quality Organization with training and promoting quality awareness across the organization.
- 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:
- Strong knowledge of quality assurance methods, tools, and relevant manufacturing processes.
- Experience with quality management software and systems (e.g., CAPA, FMEA, SPC).
- 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
- Bachelor's degree in Engineering (Master's degree preferred).
- 3-5 years of experience in cosmetics, medical device, or pharmaceuticals with a Bachelor's degree, or 1-2 years with a Master's degree.
- ASQ Certified Quality Engineer (CQE) certification is a plus.
- Strong knowledge of quality systems (ISO 9001, GMP, FDA regulations), personal care industry standards, and regulatory compliance.
- Six Sigma Green or Black Belt
- Certified Quality Engineer (CQE)
- ISO 9001 Lead Auditor Certification
- Bilingual in English and Spanish is a plus.