Quality Control Specialist- Engineer Qualification

We are seeking a Quality Control Specialist to administer quality systems and ensure compliance with good manufacturing practices. The ideal candidate will have a strong understanding of quality procedures, methods, and techniques to help implement, maintain, and improve our quality systems. This role is crucial for upholding regulatory standards and supporting ongoing process improvement initiatives.

Main Responsibilities & Tasks

• Draft and review Standard Operating Procedures (SOPs).
• Support ongoing process improvement endeavors.
• Maintain and ensure applicable regulatory and internal QMS compliance for staff training, deviation trending, and tracking.
• Provide support for internal and sponsored projects by reviewing protocols and reports.
• Work collaboratively with staff to respond to and resolve deviations and incidents.
• Follow through on corrective and preventative actions (CAPA) from deviations and audit observations.
• Maintain databases for investigations, audit observations, and CAPA.

Qualifications

• Bachelor's degree in Science, Engineering, or a related field.
• Relevant experience in a quality control or quality assurance environment.
• Knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
• Knowledge of relevant industry standard practices with a demonstrated ability to interpret these regulations.

Skills

• Proficient computer skills.
• Excellent communication skills, both written and oral, including the ability to navigate challenging situations.
• Efficient organizational skills, including the ability to manage multiple processes and priorities effectively.
• Good command of spoken and written English.
• Ability to quickly assess tasks, identify potential challenges, and communicate effectively to ensure successful execution of work.