Supplier Quality-SW Infection Control Consumables Manager (MedTech)

TL;DR

Supplier Quality-SW Infection Control Consumables Manager (MedTech): Leading the supplier quality management program for the SWICC business segment across multiple international sites with an accent on supplier qualification, auditing, and regulatory compliance. Focus on mitigating supply chain risks, driving continuous improvement through SCARs and KPIs, and ensuring adherence to ISO 13485 and FDA regulations.

Location: Remote (UK). Travel required (estimated 15–35% annually) to supplier facilities and manufacturing sites in US, Europe, Asia, and UK.

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care, cardiovascular procedures, and sterile reprocessing.

What you will do

• Strategically lead and execute the supplier quality management program for the SWICC segment across global sites.
• Qualify, approve, and re-evaluate vendors in compliance with ISO 13485:2016 and EU MDR.
• Plan and conduct scheduled and "for-cause" vendor audits to assess compliance with FDA and internal QMS requirements.
• Issue and manage Supplier Corrective Action Requests (SCARs) and facilitate root cause analysis.
• Develop supplier scorecards, performance dashboards, and improvement plans to mitigate operational risk.
• Lead, coach, and develop a team of 3–7 Supplier Quality Engineers (SQEs) across multiple sites.

Requirements

• Bachelor's degree in Engineering, Medical Devices, Life Sciences, or a related technical discipline.
• Senior-level quality experience within a regulated medical device environment.
• Deep knowledge of ISO 13485:2016 and FDA 21 CFR Part 820 supplier control requirements.
• ISO 13485:2016 or ISO 9001:2015 Lead Auditor certification required.
• Experience with APQP and PPAP processes for vendor qualification.
• Ability to travel 15–35% annually, including international travel.

Nice to have

• Familiarity with SPD consumable products and infection control supply chains.
• Knowledge of EU MDR 2017/745 and post-Brexit MHRA requirements.
• ASQ Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
• Experience with quality integration activities related to M&A or site transfers.

Culture & Benefits

• Competitive salary and bonus scheme.
• Private healthcare and Employee Assistance Programme.
• Flexible working patterns and family-friendly policies.
• Electric company vehicle and home charging point for field-based teams.
• Travel and subsistence allowance.