Senior Quality and Design Assurance Engineer

Senior Quality and Design Assurance Engineer | Ref · Sigmar

Senior Quality and Design Assurance Engineer

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• Lauryn Flanagan Higgins
• lfhiggins@sigmar.ie
• +353 91 455 306

• Location: Galway
• Contact email: lfhiggins@sigmar.ie
• Sector: Engineering
• Contact phone: +353 91 455 306
• Job type: Full Time
• Job ref: LFHQADA1123
• Salary: Negotiable
• Published: 5 days ago
• Contact email: lfhiggins@sigmar.ie
• Consultant: Lauryn Flanagan Higgins

Job description

About Your New Employer You will work for a start-up medical device company in Galway who focus on finding solutions in palliative care. You will work onsite with them in Mervue, Galway. They are looking for a candidate who has previous experience working in a quality department for a medical device company, with a strong knowledge of quality systems, design assurance and regulatory affairs. About Your New Job As a Senior Quality Assurance/Design Assurance Engineer you will…

• Be responsible for the development and application of the quality system.
• Develop, implement, and maintain Quality Management Programs aimed at optimizing product quality and processes.
• Support the implementation of Supplier Management Plans/Agreements with Suppliers.
• Develop, issue, and implement QA documentation.
• Establish and maintain appropriate procedures to ensure compliance with regulatory requirements.
• Review and analyse whether current products and processes comply with standards such as the QSRs, ISO 13485, EU MDR, etc.
• Partner with R&D ep ensure the proper application of design controls, risk management, and the investigation of design failures.
• Perform design assurance activities.
• Prepare Standard Checklists for all the applicable regulatory standards.

What Skills You Need

• Honours Bachelor’s Degree in an Engineering or related field
• Minimum of 5 years’ experience in a quality role, preferably in QUALITY Systems or Supplier Quality in a medical device company
• Experience with medical device regulations including GMP, QSR and ISO standards.
• Proven knowledge of design verification and validation

What’s on Offer

• Competitive Salary
• Flexible Working Hours

What’s Next Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306 Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available. Apply Now Save job

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