What are the responsibilities and job description for the QUALITY ASSURANCE MANAGER position at Panhandle Products LLC?
About the Role:
The Quality Assurance Manager plays a critical role in ensuring that all manufacturing processes and products meet stringent quality standards and regulatory requirements. This position is responsible for developing, implementing, and maintaining comprehensive quality systems that align with industry best practices and ISO 13485 standards. The manager will lead corrective action initiatives to address quality issues, drive continuous improvement, and mitigate risks throughout the production lifecycle. Collaborating closely with cross-functional teams, including suppliers and production staff, the role ensures that quality programs are effectively integrated and sustained. Ultimately, the Quality Assurance Manager ensures that the organization consistently delivers safe, reliable, and compliant products to customers while fostering a culture of quality excellence.
Minimum Qualifications:
- Bachelor’s degree in Engineering, Quality Management, or a related field.
- Minimum of 5 years of experience in quality assurance within the manufacturing industry.
- Proven expertise in quality systems, including ISO 13485 compliance.
- Strong knowledge of corrective action processes and quality program development.
- Experience managing supplier quality and conducting supplier audits.
Preferred Qualifications:
- Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification.
- Experience with medical device manufacturing or regulated industries.
- Advanced training in root cause analysis and risk management methodologies.
- Familiarity with Lean Six Sigma or other continuous improvement frameworks.
- Experience working with cross-functional teams in a matrixed environment.
Responsibilities:
- Develop, implement, and maintain quality management systems in compliance with ISO 13485 and other relevant standards.
- Lead investigations and root cause analysis for quality issues, and develop corrective and preventive action plans to resolve them.
- Manage supplier quality by conducting audits, evaluating supplier performance, and collaborating on improvement initiatives.
- Oversee internal quality audits and inspections to ensure adherence to quality processes and regulatory requirements.
- Train and mentor quality assurance staff and cross-functional teams on quality standards, processes, and best practices.
- Collaborate with manufacturing, engineering, and regulatory teams to integrate quality considerations into product development and production.
- Monitor quality metrics and prepare detailed reports for senior management to support data-driven decision making.
- Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize quality processes.
Skills:
The required skills, such as Quality Systems, Corrective Action, and Quality Assurance, are applied daily to develop and maintain robust quality frameworks that ensure compliance and product excellence. The manager uses expertise in Quality Programs and Supplier Quality to evaluate and improve supplier performance, ensuring that all inputs meet stringent standards. Implementing Corrective Action Plans involves detailed root cause analysis and collaboration with multiple departments to resolve quality issues effectively. Knowledge of ISO 13485 guides the establishment of regulatory-compliant processes critical in manufacturing environments, particularly in medical device production. Preferred skills like Lean Six Sigma and advanced risk management enhance the ability to drive continuous improvement and foster a proactive quality culture across the organization.