Senior Quality Assurance Engineer

hace 14 horas

Tijuana, Baja California, México Corza Medical A tiempo completo

**About Corza Medical**

We are a medical device company dedicated to delivering exceptional quality and innovation in our products. Our team is passionate about making a difference in people's lives.

**Job Summary**

We are seeking a highly skilled Senior Quality Assurance Engineer - Product Development to join our team. This role will be responsible for ensuring the highest standards of quality in our product development process.

**Key Responsibilities**

- Develop and maintain quality engineering methodologies to ensure the delivery of safe and effective products
- Lead quality assurance efforts in design and development, guiding teams in supporting quality disciplines and practices
- Appropriately document experiment plans and results, including protocol writing and reports
- Investigate, resolve, and prevent product and process nonconformances (e.g., CAPAs/HHEs)
- Participate in or lead teams in supporting quality decisions and practices
- Support design reviews and transfers, providing inputs on quality requirements, ensuring gap analysis, and supporting risk mitigation strategies
- Provide guidance and support to other engineers to ensure quality integrity
- Support the development and implementation of various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Work with design engineering in the completion of product verification and validation
- Assist in the development and execution of streamlined business systems effectively identifying and resolving quality issues
- Design and conduct experiments for process optimization and/or improvement
- Bachelor's degree in Engineering or equivalent education and experience required
- 3+ years of experience working in a Design Quality Engineering role within a medical device industry preferred
- Strong knowledge of quality management systems required
- Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) preferred
- Strong Knowledge of statistical analysis tools and their use in product design and manufacturing required
- Six Sigma training is a must
- Experience creating design control documentation during the whole lifecycle of the development process preferred
- Experience with previous transfer of products from design to volume manufacturing preferred
- Strong verbal and written communications skills to effectively communicate at multiple levels in the organization required
- Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner required
- Advanced computer skills, including statistical/data analysis and report writing skills required
- Experience implementing various product and process improvement methodologies preferred
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment required
- Fluent in Spanish and English required

**Compensation**

The estimated annual salary for this position is around $120,000, considering the location in Tijuana, Mexico and the senior level of the role.

**What We Offer**

- Competitive compensation package
- Opportunity to work with a dynamic and innovative team
- Collaborative and supportive work environment
- Professional growth and development opportunities
- Recognition and rewards for outstanding performance
- Comprehensive benefits package including health insurance, retirement plan, and paid time off
- Access to cutting-edge technology and resources
- Opportunities for career advancement and professional growth

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