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Sr. Quality Engineer

hace 4 semanas

Heredia, Costa Rica TE Connectivity A tiempo completo

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

**About the position**:
**Responsibilities**:

- Complete validation activities for a label printing system; global implementation.
- Provide guidance and support to all internal and external departments to ensure understanding and compliance with the requirements of cGMP as applied to the validation program set down by company procedures and regulatory standards.
- Adhere to regulatory standards: 21CFRPart820, 21CFRPart11, Annex11, ISO13485:2016.
- Execute site validation strategies, protocols and reports ensuring compliance to all relevant corporate and regulatory quality procedures and standards. Track and report progress.
- Co-ordinate validation activities (VS/URS/FDS/SDS/FS/IQ/OQ/PQ/RTM/Data Migration/other).
- Ensure Test Scripts are completed as per the company’s Good Documentation Practice (GDP) SOP and project’s Validation Plan requirements. Review executed test scripts and share feedback.
- Investigate and document test deviations. Ensure their successful resolution in accordance with the site procedures.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving issues.
- Proactively liaise with project leaders, IT professionals and Local Implementation Team to ensure project milestones are met.
- Administer validation files and ensure Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
- Organize and provide validation related training to project personnel.
- Provide validation expertise for the risk assessment process.
- Reporting directly to the Global Software Systems Manager and to other Global Senior Quality Managers as required.

**Minimal requirements**
- Bachelor or master’s degree in science/Engineer/Software discipline.
- 5 years of related experience, including 3+ years' experience supporting software quality/compliance or software assurance.
- Working knowledge of regional and international quality system requirements including 21CFR 820, ISO 13485, CFR Part 11 and cGxP. Experience with IEC 62304, IEC 82304, GDPR an ISO 14971 is an advantage.
- Must have a good understanding of quality system requirements and how each quality system element connects.
- Experience in working with “Agile” software development methodologies and can engage at a technical level with software development teams and testers is desirable.
- Comfortable speaking and presenting to leadership.
- Strong written and verbal communication skills.
- Creative and innovative thinking skills
- Experience managing projects and project deliverables to completion.
- Comfortable working independently and as part of a team.
- Responsible for adhering to budgets
- Availability to travel

**Competencies**:

- Values: Integrity, Accountability, Teamwork, Innovation