Our client is a global medical product provider seeking a Quality Engineer to lead site-level quality assurance programs and continuous improvement initiatives to ensure compliance with regulatory and industry standards. This role is responsible for developing, implementing, and maintaining systems that align with cGMP, ICH Q7, IPEC guidelines, ISO standards, and FDA requirements.

Located in Phillipsburg, NJ

18 month contract w/ extension

Pay: $35-44/hour

Key Responsibilities

Lead programs and improvement initiatives to ensure the effectiveness of the Quality Management System (QMS) in alignment with ISO and GMP requirements
Manage and conduct customer complaint investigations, including direct interaction with customers and raw material suppliers
Plan, host, and lead audit activities including GMP, regulatory, customer, and internal audits; implement corrective actions to address audit findings
Perform internal audits across multiple sites and support supplier audits as needed
Own and maintain Corrective and Preventive Action (CAPA) processes, ensuring timely and effective resolution of quality issues
Drive continuous improvement efforts related to global quality metrics, with a focus on complaint resolution and CAPA effectiveness
Conduct statistical analysis, process trending, and support validation activities for new products and process changes
Collaborate with supplier quality teams to resolve quality-related issues impacting site performance and customer satisfaction
Investigate and resolve quality issues across all departments

Qualifications

Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field (or equivalent experience)
Experience in a regulated environment (pharmaceutical, chemical, microelectronics, or related industry)
Strong knowledge of cGMP, ISO standards, and regulatory requirements
Experience with CAPA, audits, validation, and complaint investigations

"This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!”

#INDBH

Astrix

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