About the Role:

The Quality Assurance Manager will lead and oversee the development, implementation, and maintenance of quality management systems to ensure products and services meet or exceed regulatory and customer requirements. This role is pivotal in driving continuous improvement initiatives through effective corrective and preventive actions, ensuring compliance with industry standards such as ISO9001. The manager will collaborate cross-functionally with suppliers, production, and regulatory teams to uphold quality programs and supplier quality standards. They will analyze quality data to identify trends, mitigate risks, and implement robust quality processes that enhance overall operational efficiency. Ultimately, the Quality Assurance Manager ensures that the organization consistently delivers safe, reliable, and high-quality products to the market while maintaining compliance with all applicable regulations and standards.

Minimum Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in quality assurance within a regulated industry, preferably medical devices or pharmaceuticals.
• Proven expertise in quality systems management, including ISO9001 compliance.
• Strong knowledge of corrective and preventive actions (CAPA) and root cause analysis methodologies.
• Experience managing supplier quality and conducting supplier audits.

Preferred Qualifications:

• Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification.
• Familiarity with risk management standards.
• Proficiency with quality management software and data analysis tools.

Responsibilities:

• Develop, implement, and maintain quality management systems in compliance with ISO9001 and other relevant standards.
• Lead investigations and root cause analysis for quality issues, driving corrective and preventive action plans to resolution.
• Manage supplier quality assurance activities, including audits, performance monitoring, and improvement initiatives.
• Collaborate with cross-functional teams to integrate quality processes into product development and manufacturing.
• Monitor quality metrics and prepare reports to communicate quality performance and improvement opportunities to senior management.
• Ensure compliance with regulatory requirements and prepare documentation for audits and inspections.
• Train and mentor quality assurance staff to promote a culture of quality and continuous improvement.

Skills:

The Quality Assurance Manager will utilize their expertise in quality systems to design and maintain compliant processes that ensure product integrity. Their skills in corrective action and preventive action planning will be essential for identifying root causes of quality issues and implementing effective solutions to prevent recurrence. Knowledge of supplier quality management will enable them to assess and improve supplier performance, ensuring materials and components meet stringent quality standards. Familiarity with ISO9001 and other regulatory frameworks will guide their daily activities to maintain compliance and prepare for audits. Additionally, strong analytical and communication skills will support collaboration across departments and the presentation of quality metrics to leadership, fostering a culture of continuous improvement.