Job Description

The person on this position will be responsible for ensuring customer and regulatory requirements related to medical device manufacturing are fully met, from order receipt, raw material definition, production execution, and final shipment, including all required product documentation. Supports the development and continuous improvement of internal systems and procedures to ensure compliance with customer requirements, ISO 13485, FDA 21 CFR Part 820, and GMP regulations. Accountable for the management and control of all measuring equipment.

Key Responsibilities

• Lead and develop the Quality team, ensuring effective support for product realization and process quality assurance activities.
• Maintain and continuously improve the Quality Management System in compliance with ISO 13485, FDA 21 CFR Part 820, GMP regulations, and customer-specific requirements.
• Ensure successful completion of customer, regulatory, and certification audits while maintaining ongoing compliance with applicable standards and regulations.
• Act as the primary quality representative for customers, supporting new projects, quality issues, audits, change management activities, and continuous improvement initiatives.
• Drive corrective and preventive actions (CAPA), root cause investigations, and problem-solving activities to improve product quality and operational performance.
• Oversee quality performance metrics, customer scorecards, and quality objectives, ensuring achievement of quality and delivery targets.
• Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma, and statistical process control methodologies.
• Ensure effective implementation and control of production processes, validation activities, inspection methods, and quality documentation.
• Manage calibration and measurement systems, ensuring all inspection and measuring equipment remains compliant and properly maintained.
• Oversee First Article Inspection (FAI) processes, control plans, process validation activities, and customer approval requirements.
• Collaborate with cross-functional teams to support product development, manufacturing improvements, process changes, and risk mitigation activities.
• Ensure compliance with customer change management requirements and maintain approval status for all controlled processes.
• Monitor manufacturing performance and quality data to identify trends, risks, and opportunities for improvement.
• Support budget planning and cost control activities related to quality operations and continuous improvement programs.
• Develop employee capabilities through coaching, training, and performance development while fostering a culture of quality, compliance, and continuous improvement.
• Promote strong communication and collaboration with customers, suppliers, regulatory authorities, and internal stakeholders to ensure business objectives are achieved.

Our Requirements

• Bachelor's degree in Engineering, Quality Management, Manufacturing, Life Sciences, or a related field.
• Minimum 5 years of experience in Quality Management within a regulated manufacturing environment, preferably medical devices, aerospace, or other highly regulated industries.
• Previous leadership experience managing Quality Engineers, Quality Specialists, and cross-functional teams.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, CAPA, risk management, and quality system requirements.
• Proven experience maintaining and improving Quality Management Systems and supporting external certification audits.
• Experience working directly with customers, regulatory bodies, and external auditors.
• Strong understanding of manufacturing processes, process validation, measurement systems, calibration, FAI, SPC, and statistical sampling techniques.
• Experience leading continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Knowledge of change management processes and customer approval requirements within regulated industries.
• Experience managing quality metrics, customer scorecards, corrective actions, and quality improvement programs.
• Ability to analyze complex quality data, identify trends, and implement effective corrective and preventive actions.
• Experience supporting new product introduction (NPI), process development, and customer-specific quality requirements.
• Strong project management, organizational, and problem-solving skills.
• Excellent communication and stakeholder management skills with the ability to collaborate across all organizational levels.
• Proficiency in Microsoft Office and quality-related systems and tools.
• Fluent English, both written and spoken.
• Strong customer focus, leadership mindset, and commitment to continuous improvement.
• Ability to work effectively in a fast-paced manufacturing environment while ensuring compliance with regulatory and customer requirements.