Quality Engineer

Quality Engineer

Quality Engineer leads site quality assurance programs and continuous improvement initiatives. This role is responsible for ensuring compliance with cGMPs, ICH Q7, IPEC guidelines, ISO standards, and FDA regulations. The position supports key quality systems including CAPA, complaint investigations, audits, validation, and statistical process control.

Pay range: $36 - $43/hour on W2 as per your experience Contract Length: 12 Months with the possibility of extension

Key Responsibilities

• Lead programs and improvement activities to maintain and enhance the Quality Management System in alignment with ISO and GMP requirements
• Manage customer complaint investigations, including direct interaction with customers and raw material suppliers
• Plan, lead, and execute audit activities (GMP, regulatory, customer, and internal audits); identify gaps and implement corrective actions
• Perform internal audits across multiple sites and support supplier audits as needed
• Own and manage CAPA (Corrective and Preventive Action) processes to ensure effective resolution of quality issues
• Ensure ongoing cGMP compliance and drive continuous improvement initiatives
• Provide GMP and GDP training to site personnel
• Monitor and improve global quality metrics, especially complaint resolution timelines and CAPA effectiveness
• Support Management of Change processes
• Conduct statistical analysis, process trending, and validation activities for new and existing products
• Collaborate with supplier quality teams to resolve quality-related issues
• Work cross-functionally with operations, R&D, procurement, and commercial teams to address product and process quality concerns
• Serve as a key point of contact for customers and host audits, including certification and surveillance audits
• Perform additional duties as assigned

Required Qualifications

• Bachelor's degree in chemistry or a related scientific field
• Minimum of 5 years of experience in quality engineering or a related role
• At least 3 years of experience in a GMP manufacturing environment
• 3–5 years of experience in Quality Assurance
• Experience in pharmaceutical, biotechnology, or chemical industries
• Strong understanding of cGMP and ISO 9000 standards

Skills & Competencies

• Excellent written and verbal communication skills
• Strong analytical and problem-solving abilities
• Knowledge of chemical nomenclature and quality control testing methods
• Ability to lead cross-functional teams and influence without authority
• Strong organizational and project management skills
• Ability to work effectively in a matrixed environment
• Detail-oriented with a high level of accuracy

Pride Health offers eligible employees' comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.