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Senior Quality Engineer/Quality Manager

County Cork
Pay
€ 65000 - 75000 Per year
Hours
Full time
Type
Permanent
Job level
Qualified (non-manager)
Posted
8 May 2019
Closes
5 Jun 2019

Job Description

The primary responsibility is in providing Quality Engineering support to NPI (New Product Introduction), Operations, Engineering and Quality Management functions.

Job Responsibilities:

* Assist with development of quality and operating systems to assure alignment with current GMP/QSR, and ISO requirements.

* Manage Associate Quality Engineers and Quality Engineers as required.

* Lead Audit backroom operations for external audits.

* As assigned, participate in new product transfers and be responsible for the development of quality plans, verification of engineering tests and measurement practices for new and existing products using QA Tools.

* Active participation in the review of engineering specifications to assure that quality assurance requirements are met and designs are successfully transferred into manufacturing.

* Development of process controls using valid statistical techniques inclusive of SPC systems, sampling plans, correlation analysis etc.

* Takes a leadership role in assuring all activities in the area of equipment and process validations meet FDA and EU regulatory requirements.

* Development of IQ/OQ, Process Validation test protocols and reports to support product development and manufacturing process changes in compliance with customer's control procedures.

* Performs special projects and other related duties as assigned.

Skills, Abilities and Education

* A bachelor's degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required.

* Preferred experience: minimum of three (3) years' experience in medical device quality assurance with a background of working in a regulated manufacturing environment.

* Experienced in Process Validation to Medical Device Regulatory requirements.

* Ability to develop and write protocols, validation reports, engineering reports, etc.

* Experience in Project Management.

* Working Knowledge in Analytical, Statistical techniques including SPC and inspection and test methodologies

* Demonstrated knowledge in FDA and ISO requirements including recent QSR experience. Participation in FDA & other Regulatory bodies audits is desirable.

* Excellent written and verbal communication skills.

* Excellent interpersonal and organizational skills working with the domestic and global organisation sites and our customers.

* Ability to work in a high-intensity, fast-paced environment.

* Creative thinking and ability/desire to think "outside of the box".

* Team player

Ref: KMQE

Seven Healthcare - 14 jobs https://www.healthjobs.co.uk/Images/Default/recruiters/Thumbnail/73644cd0-6700-48e9-a6e4-5438b4759f5c131236155405703565.png
This job was posted to Biomedical, Medical sales, Pharmaceutical in County Cork

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