Position Summary:
We are seeking an experienced Senior Quality Manager to oversee and maintain the quality systems across our two manufacturing plants. This role will take full responsibility for ensuring compliance with ISO 9001, AS9100, and ISO 13485 standards. The Senior Quality Manager will lead quality initiatives, manage quality assurance and control activities, and drive continuous improvement. This position plays a critical role in achieving operational excellence and delivering high-quality products that meet our stringent industry standards.
Key Responsibilities:
Quality Systems Management
* Oversee and maintain compliance with ISO 9001, AS9100, and ISO 13485 standards across both plants.
* Develop, implement, and improve quality management systems (QMS) to ensure consistent product quality and compliance.
* Serve as the main point of contact for quality-related audits and assessments, leading audits and coordinating follow-up actions.
Quality Assurance & Control
* Lead quality assurance (QA) and quality control (QC) teams to monitor, inspect, and test processes and products, ensuring adherence to specifications.
* Establish, monitor, and report on key quality metrics and develop action plans to address areas of improvement.
* Ensure that the QA/QC processes, including documentation and records, meet the compliance requirements of ISO 9001, AS9100, and ISO 13485.
Continuous Improvement
* Drive continuous improvement initiatives to enhance quality and operational efficiency, working closely with plant teams.
* Use root cause analysis, corrective action, and preventive action processes (CAPA) to address and resolve quality issues effectively.
* Develop training programs to educate staff on quality standards, problem-solving techniques, and continuous improvement methodologies.
Leadership & Team Development
* Provide leadership, direction, and mentorship to the quality team, promoting a culture of quality excellence.
* Collaborate cross-functionally with production, engineering, and supply chain teams to ensure quality standards are upheld throughout the manufacturing process.
* Foster an environment of accountability, ownership, and proactive problem-solving within the quality team.
Reporting & Communication
* Regularly report quality metrics, challenges, and improvement initiatives to the Plant Manager and senior leadership.
* Act as a liaison between the plant and other quality, regulatory, and certification bodies, representing the company professionally and ensuring compliance.
Required Qualifications:
* Bachelor’s degree in Engineering, Quality Management, or a related field (advanced degree preferred).
* 8+ years of experience in quality management, preferably within manufacturing environments that require adherence to ISO 9001, AS9100, and ISO 13485 standards.
* Demonstrated expertise in quality management systems, regulatory compliance, and continuous improvement methodologies.
* Strong knowledge of quality tools, root cause analysis, CAPA, Six Sigma, Lean, or other improvement processes.
* Proven experience leading and developing teams, with a collaborative and solution-oriented approach.
Preferred Skills:
* Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or other relevant quality certifications.
* Excellent analytical, communication, and leadership skills.
* Experience with quality management software and statistical process control (SPC) tools.
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