Quality Assurance Engineer II
hace 1 semana
We are seeking a highly motivated Quality Assurance Engineer II to join our team in Mexicali, Mexico.
The successful candidate will be responsible for providing quality support for new products and product improvements from concept through design and validation, and into production through stable operations.
This role is part of our cross-functional project teams that support new product development and quality improvements. The ideal candidate will lead investigation, corrective/preventive action, and implementation of quality improvements.
Key responsibilities include:
- Participating in cross-functional project teams to support new product development and quality improvements;
- Leading investigation, corrective/preventive action, and implementation of quality improvements;
- Managing the supplier quality program, participating in selection and qualification of new suppliers, managing the supplier audit program, and supplier corrective actions;
- Providing guidance and assistance to engineering during all phases of new product development and manufacturing, including design and document reviews, risk assessment, hazard analysis, problem solving, verification, and validation;
- Performing technical reviews and/or developing key documents, including quality and reliability plans, FMEA, product and process validation plans & reports, and sample size justification;
- Developing and implementing robust measurement systems through application of tools such as Measurement System Analysis (MSA);
- Serving as the quality focal point for the project team and the customer on all items related to safety and regulatory compliance, as well as compliance with all Breg procedures;
Required qualifications include:
- A BS degree in a scientific discipline with 2-5 years related medical device experience or an MS degree in a scientific discipline with 2+ years related experience or an equivalent combination of education and experience;
- ASQ (CQE, CRE, CQA, etc.) certifications desired;
- Experience with electromechanical devices preferred;
- Must have proven experience with FDA audits or regulated body audits such as ISO;
- Must have risk management experience, including generating risk analysis and applying the concepts and principles of ISO 14971;
- Lean Manufacturing and Project Management experience preferred;
- Must be proficient in validation and evaluation methods;
We offer a competitive salary of approximately $80,000-$110,000 per year, depending on experience. Benefits include health insurance, retirement plan, paid time off, and professional development opportunities.
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