The Quality Assurance Specialist at OBP Medical will be responsible for overseeing quality systems processes including supplier quality, investigation systems, change management, CAPA, and compliance. The role involves managing cross-functional teams, performing root cause analysis, and supporting continuous improvement efforts. The specialist will also be responsible for document control, supplier management, quality metrics, and audit reporting to ensure high standards of quality assurance are met across operations.

Key Responsibilities:

• Review, approve, and maintain company Standard Operating Procedures through electronic Document Quality Management System.

• Oversee change management by tracking and facilitating investigations and ensuring timely closure of quality events.

• Handle deviations, nonconformances, and complaints by leading investigations and ensuring resolution.

• Support supplier qualification, reassessments, and ensure adherence to quality agreements.

• Perform trending analysis and reporting on quality indicators.

• Support compliance audits, ensuring corrective actions are implemented and tracked.

• Assist in root cause analysis for complex quality issues and risk mitigation efforts.

• Collaborate with cross-functional teams to maintain consistency in quality systems.

Requirements:

• Bachelor’s degree or Associate’s degree in related fields with 3-5 years of relevant experience.

• Strong knowledge of quality principles and experience in using tools like Master Control or similar eQMS.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

• Excellent communication skills with the ability to work effectively in a team and handle multiple tasks under pressure.

• Knowledge of regulatory standards and experience in managing quality assurance processes in a medical or similar industry.

Benefits:

• Competitive salary and comprehensive benefits package, including medical coverage, 401(k), paid time off, and fertility benefits.

• Opportunity to work for CooperSurgical, a leader in fertility and women’s healthcare, with a commitment to innovation and employee growth.

Selection Process:
The hiring process includes an initial screening, followed by an interview and possible skills assessment to ensure alignment with the role’s requirements.