Director of Quality

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.

Our Strategy and Purpose

• 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

QMS Leadership & ISO 9001 Compliance

• 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.

Audits and Compliance

• 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.

Manufacturing and Process Quality

• 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 products, processes, equipment, and documents are assessed for quality impact, documented, and approved before implementation.
• Supplier Quality: Participate in the selection and qualification of key suppliers and subcontractors (CMOs/CDOs), maintaining the Approved Supplier List (ASL), conducting supplier audits, and monitoring supplier performance.
• Material Review Board (MRB): Chair MRB for non-conforming material, components, or finished kits.
• Represent Quality in product development teams/projects. Work with Engineering and other functions to develop and execute plans including quality plan, risk management, Process Failure Mode and Effects Analysis (PFMEA), control plans, production part approval process (PPAP), part qualification checklist (PQC).

Leadership and Continuous Improvement

• Quality Culture: Champion a strong, positive quality culture throughout the organization through effective communication, training, and leadership by example.
• Training: Develop and deliver quality-related training programs (e.g., QMS principles, RCA, internal auditing) to personnel across all departments.
• Metrics and Improvement: Develop and monitor key quality metrics (KPIs) to identify trends, opportunities for improvement, and drive Lean/Six Sigma initiatives to enhance process efficiency and product quality.

Environmental, Health & Safety

• Establish and maintain the company’s safety management system and applicable processes.
• Conduct training in accordance with internal & external safety standards.
• Lead & maintain Risk Assessments, Safe working practice, safety audits and policy/procedure generation for all Health, Safety and Environmental aspects within the business.
• Responsible for accident & incident investigations and reporting.
• Ensure site contractors are working to relevant safety standards.
• Work as directed by manager.

EDUCATIONAL REQUIREMENTS, QUALIFICIATIONS, and TRAININGS

• 5 years of experience in a Quality role within a fast-paced manufacturing or contract environment.
• Strong knowledge of core quality tools (e.g. FMEA, Control plans, SPC, Root Cause Analysis)
• Preferred experience in a strong lean manufacturing environment, possessing an ability to engage our team in lean exercises such Kanban Systems Implementation, Visual Management, 5S, Value Stream Mapping, Waste Elimination.
• Proven experience driving on-time performance and managing quality in a multi-project environment.
• Demonstrated expertise in implementing and managing ISO 9001 approvals.
• Lean Six Sigma – Yellow/Green belt is a plus.
• IOSH Managing Safety or equivalent is a plus.
• ISO 9001 Lead Auditor Certification.
• 3D modeling experience required (SolidWorks a plus)
• Ability to interpret Geometric Dimensioning and Tolerancing (GD&T)
• Operating in a highly regulated industry (Pharma, automotive, aerospace etc.)
• Ability to champion change and effectively manage the implementation of new ideas.
• Knowledge of quality systems and standards
• Ability to learn modern technology in a fast-paced environment
• Excellent ability to communicate orally and in writing in English.
• Well-developed literacy, numeracy and computer skills with a technical aptitude.
• Strong understanding of customer and market dynamics and requirements.
• This position may require travel within the UK, Europe and USA.
• This position is on-site 5 days per week.

COMPUTER AND SOFTWARE REQUIREMENTS

• Experience with Epicor (ERP) a plus.
• Microsoft: Office 365; SharePoint; Teams; Visio; and OneNote preferred.
• Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
• Ability to work with general office equipment.
• Ability to work with and understand databases a must and the ability to learn technical skills.

PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

• Shall have adequate vision, reading, writing, and documentation skills, and hearing to perform the essential functions of the job.
• Must have enough endurance to perform tasks over long periods of time.
• Will be engaged in speaking, sitting, walking, driving, listening, and in communicating both orally and in writing while performing his or her duties.
• Must be able to listen and respond to questions and instructions.

The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Arcmed is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position.