Antares Aguilar

Sr. Quality Eng | Chemist (QFB)

qfb.antares.aguilar@gmail.com +52 (664) 294 6599 Tijuana, Baja California, MX LinkedIn ↗
Antares Aguilar

Professional Summary

Senior Quality Engineer with 10+ years of experience in medical device and pharmaceutical industries, with strong alignment to Supplier Quality Engineering, NPD support, GMP auditing, and regulatory compliance. Proven ability to ensure suppliers deliver compliant, high-quality components and services throughout the product lifecycle. Extensive experience working independently under limited supervision, leading cross-functional initiatives, coaching teams, and driving continuous improvement in regulated environments. Strong background in ISO 13485, FDA 21 CFR 820, EU MDR, supplier qualification, inspection strategies, and risk management.

Professional Experience

Senior Quality Engineer – Supplier, Manufacturing & QA Release

Medtronic – Tijuana El Lago

2020-02 — Present

  • ▸Ensure suppliers and manufacturing deliver compliant, high-quality parts, materials, and services per Medtronic and regulatory requirements.
  • ▸Provide Quality Engineering support for supplier quality activities including PPAP review/approval, component qualification, receiving inspection, lot release, nonconformance investigations, and CAPA effectiveness.
  • ▸Develop and maintain receiving inspection strategies, sampling plans, and usage decisions in SAP QM, monitoring materials from supplier acquisition through final release and resolving quality issues in real time.
  • ▸Support supplier, resin, and material change requests through quality impact assessments, risk analysis, and cross-functional documentation review.
  • ▸Execute and approve IQ/OQ/PQ and TMV validations for components and manufacturing processes, ensuring compliance with ISO 13485, FDA 21 CFR 820, and EU MDR.
  • ▸Drive continuous improvement through Lean Six Sigma (DMAIC, SPC, FTQ) and cross-functional collaboration, while providing technical mentoring to inspectors and junior engineers.

Quality Engineer II – NPI & Manufacturing Quality

Medtronic – Tijuana El Lago

2017-05 — 2020-02

  • ▸Provided Pre-Market Quality Engineering support for New Product Development (NPD).
  • ▸Partnered with Component Engineering and Supplier Quality to qualify new suppliers and components.
  • ▸Authored and executed validation protocols and reports supporting product launches.
  • ▸Supported supplier and manufacturing quality events, driving root cause analysis and corrective actions.
  • ▸Contributed to development of control plans, inspection strategies, and acceptance criteria for new products.

Principal Laboratory Analyst (R&D)

SBL Pharmaceuticals

2014-03 — 2017-05

  • ▸Performed analytical, microbiological, and stability testing under GMP / GLP environments.
  • ▸Led analytical method validation and verification per USP and ICH guidelines.
  • ▸Authored SOPs, CAPAs, and trained laboratory personnel.
  • ▸Strengthened quality systems supporting regulatory inspections and audits.