Supplier Quality Engineer (Medical Device)

TL;DR

Supplier Quality Engineer (Medical Device): Supporting manufacturing transfer activities from project execution through product release with an accent on FAI, process validation, and APQP. Focus on driving supplier quality, managing quality documentation in SAP/QMS, and conducting on-site validations in Thailand.

Location: Willingness to travel to manufacturing sites in Thailand is required

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across Information Systems, Telecom, Life Sciences, and Engineering.

What you will do

• Support manufacturing transfer activities from project execution through product release.
• Perform and approve First Article Inspections (FAI) to ensure manufacturing readiness.
• Execute and support process validation activities, including IQ, TMV, and PQ.
• Drive Advanced Product Quality Planning (APQP) activities with suppliers.
• Prepare, review, and upload quality documentation into SAP and Quality Management Systems (QMS).
• Collaborate with program managers and manufacturing teams to resolve quality issues.

Requirements

• Bachelor's degree in Engineering, Manufacturing, Quality, or a related field.
• 7–8+ years of experience in Supplier Quality Engineering.
• Strong experience with APQP, First Article Inspection (FAI), and Process Validation (IQ, TMV, PQ).
• Hands-on experience with SAP and Quality Management Systems (QMS).
• Excellent English communication skills (C1).
• Availability to travel to manufacturing sites in Thailand.

Nice to have

• Experience within the Medical Device industry.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.

Culture & Benefits

• International community with over 110 different nationalities.
• Strong internal growth opportunities and a robust training system via the internal Academy.
• Vibrant workplace with frequent internal events, networking, and team-building activities.
• Opportunity to contribute to sustainability and social initiatives through the WeCare Together program.

Hiring process

• Initial brief virtual or phone screening call.
• Average of 3 interviews with the line manager and team members.
• Potential case study or technical assessment depending on the specific role.