A Quality Engineer is a professional who plans, develops, monitors, tests, maintains, and improves as required, the quality of products and/or processes in industries such as manufacturing and/or services, ensuring compliance with customer requirements, applicable standards and applicable regulations (21 CFR Part 820, EN ISO 13485, others applicable), identifying opportunities for improvements, recommending solutions as result of a proper investigation and definition of the root cause, and implementing required corrective and preventive actions to avoid occurrence and reoccurrence of identified opportunities. All described activities working along with manufacturing and any other company departments as required.

Understand the term manufacturing as operations. Centerpiece S. de R.L. de C.V. (Manufacturing and Sterilization sites) applies as Manufacturer based on 21 CFR Part 820 Subpart A-General Provisions Section 820.3 Definitions (o) Manufacturer.

Essential duties and responsibilities:

· Leadership & Strategy:
- Provide leadership to the Quality Inspection team,



driving a culture of quality, compliance, and continuous improvement across the organization.
- Develop and implement plans for the quality inspection team function, ensuring organizational goals are met while adhering to regulatory and safety standards.
- Participate in regular meetings with cross-functional teams (Engineering, Manufacturing, Regulatory, Operations, Others) and as required, with Customers, specific to quality compliance topics.

Quality Management Systems (QMS):
- Support to establish and maintain a robust QMS in compliance with ISO 13485, FDA 21 CFR Part 820 and other relevant regulation applicable to the company driving its continuous improvement where applicable to ensure effectiveness, efficiency, and alignment with Company and Customer expectations.
- Oversee and/or work on the implementation of corrective and preventive actions (CAPAs) to address quality issues and minimize produ

📌 Quality Engineer (Rosarito)
🏢 Centerpiece S. de R. L de
📍 Rosarito