Education / Educación:
- Bachelor's degree in Engineering or related field
Specialized Knowledge / Conocimiento especializado:
- Knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820
- ISO 13485:2003
- Canadian MDR, and Medical Device Directive
Languages required for the position / Idiomas requeridos para el puesto:
- Advanced English (oral and written).
Computer tools and knowledge level required / Herramientas informáticas y nível de conocimiento requerido:
- Strong computer skills, including Minitab, Microsoft Word, Excel, Power Point
- Possess a strong understanding of core tools (APQP, SPC, FMEA, etc.)
Qualifications / Cualificaciones:
- Problem Solving
- Strong planning/ organizational skillsCustomer Focus
- Conflict Management
- Results oriented.
Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
- Execute activities to ensure compliance that all products and services purchased by Hologic to a Third-Party Manufacturer (TPM), Original Equipment Manufacturer (OEM) and/or supplier, comply with the company's defined specifications and/or all applicable regulations where Hologic's products are going to be commercialized.
- Review and approve TPM, OEM and/or supplier DHR for release when required.
- Investigate, analyze and resolve TPM, OEM and/or supplier quality problems by conducting audits, analyzing defect trends and leading continuous improvement projects.
- Collaborate with the development of the TPM OEM and/or supplier audit plan based on the Corporate quality management system.
- Manage TPM OEM and/or supplier records so that they are complete and comply with all the requirements of the current procedure.
- Follow up on non-conformities raised during audits until objective evidence is gathered to demonstrate TPM, OEM and/or supplier CAPAs/SCAR's have been effective in eliminating previously observed non-conformances.
- Work with TPM, OEM and/or supplier to ensure its performance is regularly reported and that appropriate and timely corrective actions are implemented.
TPM, OEM and/or supplier performance will be monitored by reviewing strategic KPIs stablished by Hologic.
- Execute updates to the supplier files when required and verify that the information is complete, ensuring compliance with the necessary regulatory standards during the development and inclusion of new suppliers as well as related projects.
- Support the RMA process to TPM, OEM and/or supplier providing a detail information about the issues found and assuring all requirements are met.
- Support all TPM, OEM and/or supplier related containment activities.
- Review and approve root cause analysis and corrective/preventive actions to eliminate recurrence/potential occurrence of non-conformances related to Hologic's product.
- Work to resolve TPM, OEM and/or supplier technical issues in a timely manner to ensure continuity of supply.
- Available to travel to TPM, OEM and/or supplier site if required on a frequent basis.
- Establish and maintain a quality agreement among TPM, OEM and/or supplier& Hologic.
- Assess and approve all changes required by the TPM, OEM and/or supplier that might impact Hologic's product performance and/or specifications.
- Work with TPM, OEM and/or supplier performance improvement projects to increase TPM, OEM and/or supplier capability of consistently meeting Hologic's requirements.
Projects may include: process analysis, value stream mapping, 6-Sigma, 5S, Kaizen events, etc.
- Work with "Quality at the source "mentality within the TPM and OEM and/or suppliers.
- Confront and escalate issues in a timely manner.