Sterilization Engineer

hace 7 meses

Tijuana, México Corza Medical A tiempo completo

**Vacancy Name**
- Sterilization Engineer

**Location of Work**
- Tijuana, Mexico

**Employment Type**
- Full Time Employee

**Our brand promise**
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.- **Remarkable service**
A seamless, personal process designed around you and your needs.
- ** Trusted performance**
Our product family is the result of years of experience championing surgeons and listening to their expertise.
- ** Outstanding value**
No matter the surgical specialty, we deliver quality products for all markets.

**Our people promise**
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
- **Job Purpose Summary**

The sterilization engineering spearheads the sterilization strategy for the corza woundclosure business by ensuring sterilization related activities are fit for the purpose of the products supported. They ensure all cleanroom and controlled environment rooms are up to regulatory standards and ensure daily practices support a relevant monitoring cadence. The sterilization engineer works with other functional areas to support product transfers, new product introductions, and sustaining of existing products. They manage product sterilization and microbiology deviations to correct and prevent their recurrence.
- **What you will do**
- Spearhead the sterilization strategy for the wound closure organization.
- Write, modify, and collaborate on sterilization validation protocols to ensure Corza products continue to meet functionality, and design standards.
- Leads sterilization and product release after sterilization activities.
- Works with R&D, Quality Engineering, and other departments on new product introductions, sustaining product changes, product transfers, and other change control management to ensure sterile products are fit for their intended use.
- Manages all sterilization deviations to understand root cause and implement appropriate corrective actions.
- Ensures cleanroom and/ or controlled environment room validations and controls are up to the relevant standards and appropriate for the product being manufactured.
- Leads any studies or analysis relevant to bioburden, cytotoxicity, pyrogenic, or other sterile-barrier related activites.

**What you will need**
- Bachelor’s degree in Engineering, Chemistry, or Microbiology.
- 3+ years of experience working in a Sterilization engineering role for medical devices.
- Strong knowledge of quality management systems as they pertain to sterilization and microbiology requirements.
- Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
- Knowledge of statistical analysis tools and their use in product design and manufacturing.
- Six Sigma training is a plus.
- Experience in working with Gamma and EtO sterilization.
- Experience with previous transfer of products from design to volume manufacturing.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Fluent in Spanish and English required

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