Quality Assurance Assistant Manager

Winthrox Laboratories is seeking a dedicated Quality Assurance Assistant Manager with a minimum of nine years of experience to enhance our quality control processes effectively. The ideal candidate will have proven expertise in Quality Management Systems and Audit Management, combined with strong team leadership skills to oversee and guide a team of 10 members. This role is pivotal in maintaining the highest standards of quality and compliance within the manufacturing and development lifecycles, ensuring all processes comply with regulatory and internal quality guidelines. The Assistant Manager will work closely with various departments to design, implement, and continuously improve quality assurance strategies, leading risk assessments and audits to identify and mitigate potential quality issues. In this position, the candidate will take ownership of audit planning and execution, including detailed risk assessments such as Failure Mode and Effects Analysis (FMEA) and Risk Priority Number (RPN) calculations. They will be responsible for managing Corrective and Preventive Actions (CAPA) effectively, ensuring that quality deviations are addressed promptly and thoroughly. Collaboration across departments is essential to promote a culture of quality and compliance. This role demands strong analytical skills and the ability to lead a team through continuous process improvements, fostering an environment that supports operational excellence and customer satisfaction.
Responsibilities

Lead and manage a team of 10 quality assurance professionals, providing guidance, mentoring, and performance management.
Develop, implement, and maintain Quality Management Systems to ensure compliance with industry standards and company policies.
Plan, organize, and execute internal and external audits to verify adherence to regulatory requirements and quality standards.
Conduct comprehensive risk assessments utilizing Failure Mode and Effects Analysis (FMEA) and calculate Risk Priority Numbers (RPN) to prioritize potential failure modes.
Oversee the Corrective and Preventive Actions (CAPA) process, ensuring timely identification, investigation, and resolution of quality issues.
Collaborate with cross-functional teams to drive continuous improvement initiatives aimed at enhancing product quality and operational efficiency.
Prepare detailed audit reports and present findings and recommendations to senior management for decision-making.
Monitor quality performance indicators and implement strategies to achieve and exceed quality objectives.
Ensure documentation and records related to quality assurance activities are accurate, complete, and compliant with company policies and regulatory requirements.
Provide training and development programs to enhance the team's knowledge and competence in quality assurance practices.