Quality Engineer_PR - send cv
CorTech
Barceloneta, PR
hace 17 días

Job Description :

Exempt Position. A Supplier Quality Engineer drives improvement and corrective action in the quality of components sourced from outside suppliers.

Provides technical support in the selection, audit and evaluation of suppliers. Develops acceptance criteria for materials.

Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. Works in compliance to AV Procedures and cGMP guidelines.

Main Responsibilities : Responsible for compliance with applicable Corporate and Divisional policies and procedures. Assesses potential new suppliers for technical, quality and manufacturing capabilities.

Provides technical support for the introduction of components from a new supplier. Generates and maintains incoming inspection procedures.

Trains inspectors to these procedures. Assists in generating component specifications. Generates test protocols, monitors testing, issues qualification test reports and approves components for use in products.

Provides input to Design Engineering on new component technology and assists in component selection with quality and reliability analysis.

Analyzes incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.

Investigates field failures related to supplier materials. Develops corrective action plan where necessary. Reviews new design specifications and provides input from quality, inspect ability and manufacturability perspective.

Initiates and completes technical activities. Prepares reports, publishes, and makes presentations to communicate findings.

Analyzes and solves problems form basic engineering principles, theories and concepts through to aa wide range of complex problems.

Understands engineering principles, theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.

Incorporates business needs of the company and has knowledge of the customer needs or our business. Cultivates internal and external network of resources to complete tasks.

Interacts with internal and external customers by meeting regularly, responding to requests and explaining procedures. Interacts cross functionally and with internal and external customers.

Serves as a consultant for supply chain, engineering or scientific interpretations and advice on significant matters. Mentors employees by sharing technical expertise and providing feedback and guidance.

Acts as a spokesperson to external suppliers. Requirements : Bachelor's degree in Engineering. 2-5 years of related work experience, or Master's degree with 0-

2 years of related work experience. Candidates must be bilingual (English / Spanish). Internal or Lead Auditor training (ISO 9001 / 13485) or regulatory / compliance knowledge and experience.

Technical / Business knowledge. General understanding of business unit / group function. Will perform this job in a quality system environment.

Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the system environment.

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