Job Description
Our client, a Medtech company based in Galway, now require a Quality Engineering Projects Specialist who will provide focused Quality and Engineering support within the Mechanical test lab. This role will support projects in new product and process development, equipment and process integration, validation testing, site operational test support and Quality system/services support.
The successful candidate will be the point of contact for Mechanical Test Lab, leading communications and interfacing with lab customers and vendors including: Operations, New Product Development, Sustaining and Original Equipment Manufacturers.
The ideal candidate will be an experienced Quality Engineer with strong project management and communication skills, with proven abilities to work with Management.
Responsibilities for Quality Engineering Projects Specialist:
Act as a technical resource within the Mechanical Test lab for review, approval and resolution of non-conformities.
Evaluates new equipment to support testing for company’s mechanical products.
Supports new product testing and equipment transfer into the Galway lab.
Ensures that Calibration and Maintenance for existing and new equipment are fully compliant with site/corporate policies and SOPs.
Initiate Equipment Risk Assessments along with associated documentation for equipment and systems.
Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.
Ensures that new equipment validations are carried out in compliance with site/corporate policies and SOPs. Proven working knowledge and application of validation techniques and associated regulatory requirements.
Understands and complies with all the regulations governing the quality systems.
Must be an effective communicator to effectively communicate timelines and changes in project milestones.
Requirements for Quality Engineering Projects Specialist:
Honours Bachelors Degree (Level 8) qualification in a STEM subject.
4+ years relevant Engineering experience, preferably supporting Quality function.
Project Management skills and experience are highly desirable.
Proven of problem solving skillset, using structure methodologies and associated application.
Proven ability in driving continuous improvement and/or process improvements to improving KPIs.
Excellent communication skills and organisation skills.
Preferred knowledge of Mechanical test methods such as: Leak, Burst, Tensile, Particulate, Lubricity, Tracking, Optical Measurement & Torsion testing.
Please phone Larry on +353 1 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter