Director of Quality

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The Senior Manager/Director of Quality & EHS is responsible for the development, implementation, and maintenance of the Quality Management System (QMS), ensuring compliance with ISO 9001 and other relevant regulatory and customer requirements. This role will drive a culture of quality and continuous improvement across all functions, including development, manufacturing, and supply chain activities for Arcmed products, while driving on‑time performance and customer satisfaction in a fast‑paced, multi‑project contract environment.

• We provide technology and supply chain solutions for the design and manufacture of precise fluid handling components for diagnostic and analytical instruments.
• We improve patient outcomes by helping solve the world’s toughest diagnostic and analytical challenges.
• We will be the recognized leader in helping engineers, scientists, and doctors to solve the world’s toughest diagnostic and analytical challenges.
• We always act with intention and drive to achieve our purpose.
• Teamwork, collaboration, and diverse opinion make us stronger.
• We are unafraid to make timely decisions, and we empower our people to make decisions, execute them and move forward.
• We value people and take the initiative and hold themselves accountable.
• Challenging the status quo helps us grow. Look for and call out improvements.

• Establish and Maintain the Quality Management System:
  Lead the design, implementation, and continuous improvement of the QMS in accordance with ISO 9001. Maintain and evolve the ISO 9001:2015 QMS tailored to business operations (Customer specs, design transfer, phase‑gated projects). Embed risk‑based thinking into project planning, change control, and deviation management.
• Documentation and Control:
  Oversee the creation, revision, and control of all quality documentation, including quality manuals, Standard Operating Procedures (SOPs), work instructions, and quality records. Oversee design transfer from engineering to production (DHF‑equivalent deliverables).
• Management Review:
  Plan and conduct QMS Management Review meetings, reporting on quality performance, objectives, and improvement opportunities to top management.

• Internal Audits:
  Manage the internal audit program, ensure scheduled audits are conducted, findings are documented, and corrective actions are effectively implemented and verified.
• External Audits:
  Serve as the primary quality representative for customer, supplier, and regulatory (e.g., ISO Registrar) audits and inspections. Maintain audit‑ready state for unannounced customer visits.
• Regulatory Monitoring:
  Stay current on IVD‑specific global regulations, industry standards, and quality best practices to ensure proactive compliance planning.
• Quality Agreements:
  Author/review customer.
• Customer Complaints & Post‑Delivery Support:
  Manage customer complaint investigations, perform trend analysis on field performance data, support CAPA and field corrective actions using our CAPA and RMA system.
• Co‑ordinate and maintain training across QMS policies and procedures, including production training records related to product and process. And any Health, Safety and Environmental where needed.

• Production Oversight:
  Establish quality processes to ensure that all contracted development and manufacturing activities meet specified quality requirements and customer agreements.
• Non‑Conformances & CAPA:
  Lead the investigation of non‑conformances (NCs), deviations, and customer complaints, driving effective Root Cause Analysis (RCA) and managing the Corrective and Preventive Action (CAPA) system for timely and robust closure.
• Lead Supplier Corrective Actions Requests (SCARs) – containment, root cause analysis, corrective action, and preventive action.
• Change Control:
  Oversee the change control process to ensure all changes to…