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Critcal Systems Engineer - HealtTech

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Date: Mar 18, 2019

Location: Monterrey, MX

Company: Celestica International Inc.

Req ID: 40089 
Region: Americas 
Country: Mexico 
State/Province: Nuevo Leon 
City:  Monterrey 

JOB OBJECTIVE:

Manage, maintain and improve the quality system for medical device manufacturing. Apply in-depth knowledge in a specific area of specialization. Work is performed within established professional standards and practices. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors and a considerable degree of judgment. Erroneous decisions or failure to achieve results may have a negative impact on the division’s/department’s operations, schedules, and/or performance goals. Work under minimum Supervision. Seek approval from others on matters outside of job/role scope. Receive instruction on specific assignment objectives and possible solutions. Unusual problems are solved jointly with manager. Work is reviewed for application of sound medical devices regulatory and quality technical judgment. May lead a work group or project team consisting of technical and support staff. Build internal and external relationships, with emphasis on those that facilitate the achievement of job/role accountabilities, such as relationships with key suppliers, customers and internal service.

 

ESSENTIAL TASK:

Provide technical expertise on assigned regulatory and quality tasks for production or customer-identified tasks. Perform assessments/risk analysis and quality audits on product, process, potential suppliers, etc. Generate product specifications and deploy to peers or suppliers. Perform material, process or product qualifications on prototype, or new materials, processes or products. Serve as the program/project quality interface on new product launches / introductions. Translate customer requirements into factory documents associated. Define process solutions that lead to through put or quality issues, evaluating root cause of problem, and evaluating effectiveness and results. Verify that specifications conform to regulations, customer, industry and company standards. Gather, analyze, sort and distribute data to understand and resolve quality issues. Create and evaluate metrics to drive the regulatory and quality improvement process

May be appointed as internal auditor, external auditor or any other RAQA related roles as required by the company.

 

KNOWLEDGE, ABILITY, EXPERIENCE:

  • Fluent English spoken and written
  • Knowledge of medical devices industry and regulatory / quality standards (Example ISO13485, FDA CFR, etc), SPC methodologies.Knowledge of manufacturing materials and processes used in medical devices production.
  • Excellent customer/supplier contact, negotiation and problem resolution skills
  • Ability to manage several projects simultaneously and coordinate multiple, changing Deadlines.
  • Ability to evaluate, diagnose and troubleshoot problems
  • Ability to evaluate materials, gather and analyze data and determine root cause of problems.
  • At least five years working experience in similar medical devices engineering position

COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) is a US$5.6 billion global leader in the delivery of end-to-end product lifecycle solutions. Our customers trust us to deliver the most advanced design, engineering and manufacturing expertise for their highly sophisticated and complex products. From advanced medical devices, to highly engineered aviation systems, to next-generation hardware solutions for the Cloud, at Celestica we manage the complexity for our customers and set the bar for quality and reliability in their markets. Our customer portfolio includes leaders in the enterprise computing, communications, aerospace and defense, industrial, smart energy, healthtech and semiconductor markets. Headquartered in Toronto, our global network spans 13 countries with 26,000 employees throughout the Americas, Europe and Asia.


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