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March 20 2018

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Job Opportunity: Senior Quality Systems & Compliance Engineer:Cardinal Health

Job description:

Senior Quality Systems & Compliance Engineer

Cardinal Health

   » Offaly
   » See description
   » Permanent full-time
   » Updated 12/03/2018
   » Cardinal Health this job is expired SaveSave Apply Now

Job detail

This is Senior Quality Engineer and will suit Somebody with strong Quality Management Systems practice in a regulated environment either Medical Devices


listing title: Senior Quality Engineer
Division: PR
Job location: Tullamore
Reporting to: SeniorQuality Systems Manager

Job Summary:
This is Senior Quality Engineer and will suit Somebody with strong Quality Management Systems practice in a regulated environment either Medical Devices
You will be responsible for maintaining the Quality Management System, evaluating the manufacturing processes for the purpose of continued compliance, along with managing third party audits.
Manage key elements of the Quality System to ensure compliance to significant standards for the business including MDSAP, ISO13485, and FDA QSR. The function will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.
Essential Functions:
   » Provide guidance and support for determining regulatory/compliance strategies to meet the requirements of established certified standards, regulations and customer requirements
   » Maintain company documentation of procedures and ensure compliance with the Cardinal Health QA/RA integration plan.
   » Support the various departments on compliance issues and CAPA investigations. Support and conduct internal audits.
   » Act as senior investigator for critical quality issues as requested by Quality Management
   » Participate with the corporate remediation team to ensure compliance to the new MDR, to include risk management as EN ISO 14971:2012 Medical Devices - Application of risk management to medical devices, Product Standards, and other standards as required.
   » supervise annual audit schedules, ensuring audit teams are fully trained to all applicable standards and auditing requirements. Conduct or participate as needed in internal audits.
   » Utilize benchmarking of best in class processes to provide information for continuous improvement.
   » Participate in the site Quality Improvement Program,
1. Support Cardinal corporate continuous improvement initiatives
2. Develop and/or deliver Quality Management System training
3. Other tasks as assigned with or without accommodation.
Minimum Requirements
suitable education
   » BS or MS in Quality Management Systems, Science, Engineering, or related field
   » Minimum of 5 years of practice in a Regulatory Compliance and/ or Manufacturing Quality environment within the medical devices sector.

Preferred expertise/Appropriate qualifications:
   » Communication: capability to communicate effectively in multi-discipline environment, and across cultures and levels of organizations
   » Project Management: capability to organize and manage multiple priorities and teams.
   » Organizational Management: capability to directly manage teams and individuals to achieve high levels of performance.
   » Medical Device industry practice desired
   » expertise of ISO Quality System Standards, MDSAP and FDA Quality System Regulation is required.
   » expertise of risk management (FMEAs), process validation, statistical process control, and statistical sampling plans is desirable.

Strong technical writing abilities.
   » capability to work with cross-functional teams, including production, quality, engineering and materials.
   » capability to multi-task and to work in a high paced environment with an consciousness of continued impact on production and the plant performance.
   » Organised and resourceful with excellent attention to detail and capability to get the job done
   » Clear written and verbal communication expertise
   » Energy and self motivation.
   » The capability to focus on problem resolution in the plant.
   » The capability to take responsibility for their own professional development and implement new approaches to doing things. Focused on simplicity of implementation.
   » An excellent record of attendance and time keeping

To apply for this position please click here
Ref: 20026787_1519044491
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Cardinal Health


   » Building 10,Cherrywood Business Park, Loughlinstown, Co. Dublin
   » 01 6200600


Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Offaly
Company Type Employer
Post Date: 03/12/2018 / Viewed 12 times
Contact Information
Company: Cardinal Health

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