Quality Engineer

Role overview

Stark Pharma Solutions Inc is looking for a detail-focused Quality Engineer to support quality assurance and compliance work in a GMP-regulated medical device and pharmaceutical manufacturing setting in Cambridge, MA. This role contributes to quality systems, investigation work, continuous improvement efforts, and adherence to FDA, cGMP, ISO 13485, and internal quality standards. The position involves close collaboration with Manufacturing, Validation, Engineering, and Regulatory teams to help protect product quality and patient safety.

Responsibilities

• Contribute to Quality Management System activities and help ensure compliance with FDA, cGMP, and ISO 13485 requirements.
• Evaluate and approve deviations, non-conformances, CAPAs, and change control records.
• Lead or support root-cause investigations and the implementation of corrective and preventive actions.
• Assist with internal, customer, and regulatory audits and inspections.
• Examine manufacturing, validation, and quality-related documents to verify compliance.
• Carry out risk assessments and assess quality impact where needed.
• Track quality metrics and identify improvement opportunities.
• Support supplier quality tasks, including qualification and ongoing performance monitoring.
• Work with cross-functional partners to make sure quality requirements are maintained across the product lifecycle.
• Help with process validation, equipment qualification, and product quality improvement efforts.

Requirements

• A bachelor’s degree in Engineering, Life Sciences, Quality, or a closely related discipline.
• At least 3 years of experience in Quality Engineering within medical device, pharmaceutical, or biotechnology environments.
• Solid understanding of FDA regulations, cGMP, ISO 13485, and quality system practices.
• Hands-on experience with CAPA, deviations, change control, and investigation workflows.
• Strong analytical thinking and root-cause problem-solving ability.
• Clear written and verbal communication along with strong documentation skills.

Additional information

This opportunity is based in Cambridge, MA and is focused on the medical device and pharmaceutical industries. The recruiter shared that the company also supports hiring across pharmaceuticals, biotechnology, medical device, and life sciences roles, and invited interested professionals to share an updated resume along with their best contact number and time to reach them.