Quality Engineer

Hims & Hers • Gilbert, AZ

34d

About The Position

We are seeking a highly motivated and detail-oriented Quality Engineer to join our team. The ideal candidate will be responsible for ensuring the quality and consistency of our products and processes through rigorous validation and quality assurance activities. This role involves designing and implementing robust quality assurance systems, overseeing validation activities, and working closely with cross-functional teams to uphold the highest standards of quality.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field
• Proven experience in quality assurance, validation, or engineering within the pharmaceutical or related industry.
• Strong understanding of pharmaceutical compounding processes, GMP (Good Manufacturing Practice), and regulatory requirements.
• Experience with validation methodologies, including IQ/OQ/PQ, and risk management tools.
• Proficient in designing and analyzing quality systems, statistical techniques, and process improvements.
• Excellent problem-solving, analytical, and communication skills.
• Ability to work in a fast-paced, collaborative environment while maintaining high attention to detail.
• Ability to work in an environment that may require standing, sitting, and the occasional lifting of up to [insert weight limit, if applicable].
• Willingness to travel as needed.

Nice To Haves

• Certification in Quality Engineering (CQE) or similar is a plus.

Responsibilities

• Validation Activities: Oversee and execute the primary role and responsibility of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with industry standards and regulatory requirements.
• Quality Assurance Process Design: Design, install, and evaluate quality assurance process sampling systems, procedures, and statistical techniques to ensure compliance and continuous improvement in product quality.
• Inspection and Testing: Design or specify inspection and testing mechanisms and equipment to monitor and assess product quality throughout the manufacturing process.
• Analysis of Production and Service Limitations: Analyze production and service limitations and standards, providing recommendations for improvements and corrective actions to maintain product quality.
• Policy and Procedure Formulation: Recommend revisions of specifications, and help formulate or revise quality assurance policies and procedures to ensure alignment with regulatory requirements and best practices.
• Cross-Functional Collaboration: Interface with all other engineering functions within the organization, including production, R&D, and regulatory affairs, to ensure that quality standards are met at every stage of the manufacturing process.
• Continuous Improvement: Collaborate with management and staff to identify opportunities for continuous improvement in quality systems, process efficiency, and compliance with regulatory standards.
• Other Projects assigned based on business needs

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees