Senior Supplier Quality Engineer
On-site · Tijuana, Baja California, Mexico
Job Summary
Senior Supplier Quality Engineer at Outset Medical in Tijuana, MX, focusing on maintaining and improving material and component quality from suppliers. Lead audits and capability assessments, analyze supplier performance data, drive corrective actions and root-cause analysis, support change orders for process improvements, manage supplier qualifications and changes, and develop monthly supplier quality trend analyses. Requires 5+ years in supplier quality, experience with regulated medical device quality systems (ISO 13485, 21 CFR 820), strong analytical/problem-solving skills, knowledge of PPAP, MSA, supplier control plans, and Six Sigma, plus Lead Auditor certification. Travel domestically and internationally as needed; English communication skills required.
Required Qualifications
- Bachelor’s degree in quality, Mechanical, or Industrial Engineering, or related field
- Minimum of 5+ years of supplier quality or working with supplier qualification projects
- Experience in a medical device or other regulated industry is required
- Strong verbal and written communication skills in English are required
- Comprehension of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971
- Able to read and understand technical data (drawings, GD&T)
- Effective analytical, technical, and problem-solving skills; applies Six Sigma methodology
- Deep knowledge of sampling plans and statistical techniques
- Lead Auditor certification
Desired Qualifications
- Certification in Quality elements such as Quality Engineering or Lean Six Sigma
- Willing to work with people in an international environment
- Flexibility to travel domestically and internationally for supplier visits and audits
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