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Quality Manager

Poziții disponibile: O poziție
Producție & Tehnică

Location: Oradea, RO

Position Objectives:


Provide direct and indirect supervision to subordinate employees performing diverse regulatory and quality roles. Work is guided by broad site objectives and sets goals to achieve objectives. Establish long-term plans/objectives and recommend changes to policies. Develop department budgets and goals. This includes establishing and developing policies for the function/unit. Accountable for projects or programs on a multi-functional, national, or regional basis. Erroneous decisions or failure to achieve goals results in critical delay in schedules and/or unit operation and may also have a company-wide affect. coordinate the activities of a section or department with responsibility for results in terms of costs, methods, and employees. Review and approve employee’s performance and recommend employee compensation; coach for improved performance and disciplines as necessary. Build cross-functional relationships where persuasive skills, negotiation skills, and considerable tact are required to gain support. Interact regularly with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. Maintains positive relationships with key customers, suppliers, etc., who have a significant impact on the success of the organization.


Duties and Repsonsibilities: 

  • Develop a comprehensive regulatory and quality compliance program for a large site integrating inputs from quality system users. Sets site wide regulatory and quality strategy and acts as the focal point for continuous improvement in these areas. Provides leadership and direction towards executing focused programs and initiatives. Oversees own direct and indirect staff while also providing mentorship across the site community in regards to regulatory and quality compliance. Develops and maintains effective measurement reporting tools to track department progress and corrective action programs
  • Ensures ongoing compliance and effectiveness with applicable standards (example ISO13485, FDA CFR, etc). Direct staff by establishing overall direction and priorities. Provides direction, and is responsible for, new manufacturing quality systems. Provide ongoing support and maintenance for existing quality systems. Directs implementation of new, and/or improvement to existing, system(s) and processes that ensure the correct documentation/information/instructions (e.g., Operating Procedures, Quality system procedures, administration of Quality management systems, i.e. forms, logs, & records) are available for use and that changes are implemented in a timely manner. Ensure that system(s) and processes meet industry standards (e.g., ISO) and customer requirements while driving toward “world class” practices and standards
  • Appointed as site management representative (deputy management representative). Reports performance and effectiveness of QMS to site management
  • May participate as internal auditor, external auditor, or any other RAQA related roles as required by the company.


  • Internal / External Audits management
  • CAPA Verifications / Management
  • Document / Protocols / Policies / ValidationsvRelease
  • QMS Management Representative
  • Product Release
  • Customer Complaints Management


  • University degree in relevant field 
  • Fluent in English (Verbal/Written) 
  • At least fifteen years working experience and ten years on a similar medical devices RAQA management position
  • Must have 3 or more Face to Face FDA inspections as the Management Representative.
  • In-depth knowledge of medical devices regulatory quality management systems and processes (Example ISO 13485, FDA CFRetc). Excellent knowledge and understanding of manufacturing environment, materials, manufacturing and business processes
  • Excellent negotiation, problem solving, coordination and team building skills.
  • Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion
  • Ability to effectively communicate with a wide variety of internal and external
  • Ability to effectively lead, manages, train and motivate a diverse group of employees to achieve goals within tight time deadlines
  • Team Work
  • Leadership
  • Root Cause Analysis

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.

Job Segment: Engineer, Quality Manager, Cloud, Design Engineer, Quality, Engineering, Technology

Quality Manager
  • Oradea

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