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Quality Assurance Manager
2 months ago
Position Overview: The Quality System Manager at Dynaflex Technologies is tasked with ensuring that all products and services adhere to established quality benchmarks and regulatory guidelines. This position is pivotal in formulating, executing, and overseeing quality management frameworks, spearheading initiatives for continuous enhancement, and safeguarding the company’s esteemed reputation for excellence within the sector.
Core Responsibilities:
- Quality Management Framework:
- Design, implement, and sustain the Quality Management Framework in alignment with ISO 13485 standards.
- Guarantee adherence to pertinent regulations and standards throughout all phases of production or service provision.
- Regularly assess and revise quality policies, procedures, and documentation.
- Quality Assurance & Control:
- Supervise quality assurance protocols, including inspections, evaluations, and audits.
- Create and execute quality assurance strategies to minimize defects and ensure uniformity in products.
- Track and analyze key quality indicators, pinpointing trends and opportunities for enhancement.
- Continuous Quality Enhancement:
- Drive continuous quality enhancement initiatives aimed at improving product quality, minimizing waste, and boosting operational efficiency.
- Collaborate with cross-functional teams to diagnose root causes of quality challenges and implement corrective measures.
- Facilitate training sessions on quality standards and best practices for staff.
- Supplier & Vendor Oversight:
- Establish and uphold quality standards for suppliers and vendors.
- Conduct audits and evaluations of suppliers to ensure compliance with organizational quality expectations.
- Engage with suppliers to address quality concerns and enhance supply chain performance.
- Customer-Centric Approach:
- Ensure that customer requirements and expectations are clearly understood and met.
- Manage customer feedback and resolve quality-related concerns promptly.
- Incorporate customer insights into the quality management process to foster continuous improvement.
- Regulatory Adherence:
- Remain informed about industry regulations and standards.
- Ensure all products and processes comply with applicable regulations, including safety, environmental, and legal standards.
- Prepare and submit necessary regulatory documentation.
- Leadership & Team Development:
- Guide and mentor the quality assurance and quality control teams.
- Cultivate a culture of quality throughout the organization.
- Establish performance objectives and conduct regular performance evaluations.
Required Qualifications:
- Bachelor's degree in Engineering, Quality Management, or a related discipline.
- A minimum of 10 years of experience in a quality management capacity, ideally within the Medical Device sector.
- Comprehensive knowledge of quality management systems, standards, and methodologies (e.g., Six Sigma, Lean).
- Experience with regulatory compliance and industry-specific standards.
- Exceptional problem-solving and analytical abilities.
- Strong leadership and communication skills.
- Preferred certification in quality management (e.g., CQE, CQM/OE).
