Lead - QA and QC

Lead - Quality Assurance/Quality Control

Colombo, Sri Lanka 

Our Wavetec team which is an end-to end provider for design, development and manufacturing of first to market health tech solutions is on the look out for a Quality Assurance and Quality Control Lead that can support in bulk executions and potential developments that maybe converted to bulk.

With a growing pipeline of bulk executions and several emerging developments expected to scale, the team is strengthening the Quality function to keep pace with the business. We’re looking for someone who thrives in fast-moving, high-volume environments, detail-sharp, and confident in building structure without slowing momentum. If you can balance rigorous compliance with practical, on-the-ground problem-solving, you’ll fit right in. 

What you’ll be doing:

• Lead the end-to-end Quality function, maintaining a compliant QMS aligned with ISO 13485, 21 CFR 820/QMSR, and EU MDR.
• Oversee document control, training, audits, CAPA, change control, and quality metrics.
• Drive Design & Development Quality through design controls, V&V, risk management (ISO 14971), and audit-ready DHF/DMR/DHR.
• Strengthen manufacturing quality with inspection plans, process capability monitoring, MRB/NCR/CAPA leadership, and yield/scrap improvement.
• Manage Supplier Quality, including qualification, audits, scorecards, corrective actions, and oversight of critical parts/FAI/PPAP.
• Lead external regulatory/Notified Body audits and internal audit programs; ensure timely gap closure.
• Oversee complaints, vigilance, trend analysis, and post-market surveillance, feeding insights into continuous product and risk updates.

What you are required to have:

• Bachelor’s or Master’s in Biomedical/Mechanical/Electrical/Industrial Engineering, Quality/Manufacturing, or related field.

• Relevant certifications (ASQ CQA/CQE/CMQ-OE, ISO 13485 Lead Auditor) are advantageous

• 7–12 years of Quality experience in medical devices (Class II/III preferred), with 3+ years in a leadership or lead role.

• Deep working knowledge of ISO 13485, ISO 14971, EU MDR, and 21 CFR 820/QMSR (or MDSAP jurisdictions).

• Hands-on with CAPA, internal audits, supplier quality, design controls, and statistical methods (SPC, sampling, Gage R&R).

• Strong documentation rigor and experience preparing for/hosting external audits (NB/FDA/MDSAP).

• Excellent cross-functional collaboration and communication.