The Quality Engineer is responsible to support implementation of the quality management system in the areas of documentation, validation, complaint management, and change control. The Quality Engineer will also support continuous improvement activities in the development and compliance of internal systems and procedures to meet ISO 22716 GMP standards, FDA quality system regulations, and other regulatory requirements applicable to cosmetic manufacturing environments.
Each CAPSUM employee will practice an individual commitment to sustainability and environmental responsibility in the workplace. We aim to steer society in a more sustainable direction for our benefit and the world.
Primary Responsibilities
• Support the Quality Manager in maintaining the Quality Management System
• Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.
• Performs quality review and approval of change control documentation as assigned.
• Conduct internal and supplier audits
• Support the non-conformance management process, along with consumer/customer complaint resolution and CAPA.
• Work with cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
• Support and contribute to validation activities including:
o Process Validation
o Computer systems validation
o Equipment commissioning, qualification, use and maintenance
o Cleaning validation
• Support the collecting and trending of quality metrics.
• Develop quality related procedures, training materials and assist in implementation.
• Support and comply with all corporate and departmental procedures and policies.
• Support batch record review.
• Performs other duties as assigned.
Working Relationships/Key Stakeholders
• Excellent oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
• Team player with the ability to work across multiple functions, cultures and disciplines
• Positive and constructive attitude
• Be accountable displaying high levels of integrity
• Able to work collaboratively with other departments and personnel to achieve goals
Physical Requirements
• Sit, bend, stoop, climb, and stand for long periods of time in one place
• Lift items up to 50 pounds or greater as needed
• Wear PPE and any other uniform requirements
Qualifications/Competencies
• Demonstrated problem solving ability
• Experience in planning, execution and reporting of equipment, cleaning and process validations
• Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, histograms, Pareto, scatter diagrams, process mapping and flow charts
• Experience producing technical documents, testing and validation plans, IQ/OQ/PQ protocols and formal procedures
• Knowledge of cGMP, OTC, ISO 22716, 21 CFR 210/211 standards
• Bachelor’s degree in engineering, Life Sciences or other concentration with applicable.
• 3+ years of experience in a Technical Quality role in a cGMP manufacturing environment (cosmetics, or pharma preferred).
About Capsum:
Founded in 2008, Capsum has become a key player in the cosmetics world in just a few years, thanks to its unique expertise in Microfluidics and its fresh, innovative vision of formulation.
The company creates unique, tailor-made products that respect the customer's brand vision. Whether for emerging creative brands or major international cosmetics groups, our products stand out for their unrivalled efficacy, visual appeal and sensory appeal.
Today, Capsum has strong CSR ambitions, double-digit annual growth and over 270 talented employees who are nurturing tomorrow's successes. The laboratories and the historic factory are based in the the south of France (PACA region - Marseille/Aix). Capsum also has a showroom in Paris and a best-in-class factory in the United States (Austin, TX).
