We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy. Read more

get any Job Done today
Menu

Start your job search now...

Reset
38435
1peopleperhourDDDCCCgmail.com
https://jobsdonedeal.co.uk/index.php?option=com_comprofiler&view=fieldclass&field=cb_cv&function=download&user=4431&reason=profile&Itemid=131

Software Quality Engineer

Location

Wellpark RdGalway

Company

SL Controls Ltd

Date added

24/07/2020

Website

http://slcontrols.com

Job Description:

In this role you will develop, establish, maintain and audit quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. You will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

A Senior Software Quality or an ambitious Intermediate level Software Quality Engineer will be considered for this role.

Responsibilities

    Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
    Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
    Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
    Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
    Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
    Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment, systems and processes.
    Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
    Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
    Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement.

Requirements

Quality Systems:

    Strong and identifiable quality systems experience in a medical devices or related environment
    Significant experience managing the quality system in a software validation environment
    Relevant academic qualifications
    Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
    Working knowledge and application of business and technical concepts, procedures and practices and general knowledge of industry practices, techniques, and standards
    Strong project management and organisational skills
    First class communication skills

Why Choose This Role & SL Controls

    An excellent compensation package which rewards high performers
    The opportunity to work clients who are global leaders in their field
    A supportive environment committed to employee development and wellness
    The opportunity to work with, help develop and improve upon industry leading technology solutions
    A collaborative and open culture where you are valued and can contribute to company initiatives and growth

About SL Controls

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. Over the past 16 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Dublin and Florida. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.

Term

Permanent / Full-time

Apply for Software Quality Engineer