Key Responsibilities:
Quality Management Systems (QMS):
Develop, implement, and maintain the QMS in line with ISO 9001, IATF 16949, or other relevant standards. Ensure compliance with applicable regulations and industry standards. Conduct regular audits (internal and external) to verify adherence to QMS requirements.
Continuous Improvement:
Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency. Use tools such as Six Sigma, Lean, and Root Cause Analysis to solve quality-related issues.
Regulatory and Customer Compliance:
Ensure products and processes comply with customer requirements and applicable standards. Act as the main point of contact for quality-related customer inquiries and audits. Collaborate with regulatory bodies and certification organizations as needed.
Documentation and Reporting:
Maintain accurate documentation, including quality manuals, procedures, and records. Prepare reports and presentations on quality performance for management review. Oversee the effective control of documentation within the QMS.
Supplier and Vendor Management:
Assess and monitor supplier quality performance. Conduct supplier audits and work with vendors to address quality concerns. Collaborate with procurement to establish quality standards for incoming materials.
Qualifications and Experience: Experience:
Proven experience in a quality engineering or quality systems role, preferably in manufacturing, automotive, aerospace, or medical devices. Experience with quality management systems and standards such as ISO 9001, ISO 13485, or IATF 16949.
Skills:
Strong knowledge of quality tools (FMEA, SPC, MSA, APQP, PPAP). Proficiency in using QMS software and tools. Excellent problem-solving, analytical, and organizational skills. Strong communication and interpersonal abilities.
Work Environment: Office and manufacturing/production environments. May require occasional travel for audits, supplier visits, or training sessions.
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Develop, implement, and maintain the QMS in line with ISO 9001, IATF 16949, or other relevant standards. Ensure compliance with applicable regulations and industry standards. Conduct regular audits (internal and external) to verify adherence to QMS requirements.
Continuous Improvement:
Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency. Use tools such as Six Sigma, Lean, and Root Cause Analysis to solve quality-related issues.
Regulatory and Customer Compliance:
Ensure products and processes comply with customer requirements and applicable standards. Act as the main point of contact for quality-related customer inquiries and audits. Collaborate with regulatory bodies and certification organizations as needed.
Documentation and Reporting:
Maintain accurate documentation, including quality manuals, procedures, and records. Prepare reports and presentations on quality performance for management review. Oversee the effective control of documentation within the QMS.
Supplier and Vendor Management:
Assess and monitor supplier quality performance. Conduct supplier audits and work with vendors to address quality concerns. Collaborate with procurement to establish quality standards for incoming materials.
Qualifications and Experience: Experience:
Proven experience in a quality engineering or quality systems role, preferably in manufacturing, automotive, aerospace, or medical devices. Experience with quality management systems and standards such as ISO 9001, ISO 13485, or IATF 16949.
Skills:
Strong knowledge of quality tools (FMEA, SPC, MSA, APQP, PPAP). Proficiency in using QMS software and tools. Excellent problem-solving, analytical, and organizational skills. Strong communication and interpersonal abilities.
Work Environment: Office and manufacturing/production environments. May require occasional travel for audits, supplier visits, or training sessions.
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