We are seeking a highly skilled and experienced Quality Manager to join our dynamic team. The Quality Manager will play a crucial role in ensuring that our products meet the highest standards of quality and compliance. The primary focus of this role will be to oversee the quality management system, issue regular reporting on key areas of quality, maintain quality agreements with contract manufacturers, lead and manage quality incidents, and effectively communicate with upper management regarding quality issues and system performance.

Responsibilities:

Quality Agreements and Compliance:

• Collaborate with contract manufacturers to establish and maintain quality agreements that outline clear quality expectations, standards, and responsibilities.
• Regularly review and update quality agreements to reflect changes in regulations, processes, or product specifications.
• Ensure contract manufacturers adhere to the established quality agreements and meet all quality requirements.

Reporting and Analysis:

• Develop and implement a comprehensive quality reporting system to monitor and assess the performance of contract manufacturers and internal quality systems.
• Analyze quality data and metrics to identify trends, potential issues, and areas for improvement.
• Prepare periodic reports for upper management summarizing quality performance, incidents, and improvement initiatives.

Quality Incident Management:

• Lead and take ownership of quality incidents, deviations, and non-conformances that arise in contract manufacturing processes or internal operations.
• Coordinate with cross-functional teams to investigate root causes of incidents and implement corrective and preventive actions (CAPAs).
• Monitor the progress of CAPAs to ensure timely resolution and closure of incidents.

Quality Systems and Continuous Improvement:

• Oversee the maintenance and improvement of the company's quality management system to comply with applicable regulatory standards and industry best practices.
• Implement continuous improvement initiatives to enhance quality processes, reduce defects, and optimize overall product quality.

Collaboration and Communication:

• Foster strong working relationships with contract manufacturers, internal stakeholders, and quality assurance teams to ensure effective communication and collaboration on quality-related matters.
• Serve as a point of contact for all quality-related inquiries from contract manufacturers and internal teams.

Audits and Inspections:

• Prepare for and participate in quality audits and inspections, both internally and with contract manufacturers and suppliers as needed.
• Address any findings or observations from audits and inspections and ensure prompt remediation.

• Bachelor's degree in a relevant scientific or engineering field.
• Proven experience as a Quality Manager or a similar quality management role within the manufacturing industry.
• Thorough understanding of quality management systems, quality agreements, and regulatory requirements in the industry.
• Strong analytical skills and the ability to interpret data to drive informed decisions.
• Excellent communication and interpersonal skills to liaise with stakeholders at all levels of the organization.
• Problem-solving and decision-making abilities to lead and resolve quality incidents effectively.
• Must have experience with FDA 21 CFR part 211, ISO 22716, or equivalent GMP Standards
• Demonstrated leadership skills with the ability to guide and motivate cross-functional teams.
• Quality certifications (e.g., ASQ Certified Manager of Quality/Organizational Excellence) are a plus.

As the Quality Manager, you will be instrumental in upholding our commitment to delivering high-quality products to our customers while maintaining compliance with regulatory standards. If you are a proactive, detail-oriented, and results-driven professional with a passion for quality assurance, we encourage you to apply and join our team.

Annual Base Compensation: 93,000-120,000

Diversity is a core value at Living Proof. We are passionate about building and sustaining an inclusive and equitable working and learning environment for all employees. We believe every member on our team enriches our diversity by exposing us to a broad range of ways to understand and engage with the world, identify challenges, and to discover, design and deliver solutions. Equal Opportunity/Employer/Veterans/Disabled.