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  • 2 weeks ago

jobs description

Quality Assurance Engineer

As a Quality Assurance Engineer, you'll play a pivotal role in ensuring that our products meet safety, quality, and industry standards. Reporting to the Quality Engineering Manager, your responsibilities will include identifying defects, implementing corrective actions, and maintaining quality control throughout the software development process. You'll collaborate with software developers, document test results, and ensure compliance with quality standards.

Key Responsibilities:

Adherence to Policies and Procedures:
• Strictly follow company policies and procedures.
• Conform to the requirements of the Quality and Environmental Management System.

Quality Management:
• Maintain thorough knowledge of all production processes and quality management systems.
• Review, update, and maintain existing quality processes and procedures.
• Raise the quality profile and operating standards within the organization.

Performance Metrics and Continuous Improvement:
•... Deliver on key performance indicators (KPIs) to achieve business goals.
• Initiate and drive continuous improvement programs.
• Lead and coordinate process and product validations.

Issue Resolution:
• Investigate root causes of quality issues.
• Implement timely and effective corrective actions to prevent reoccurrence.
• Oversee non-conforming material, customer complaints, and corrective actions.

Quality Documentation and Audits:
• Maintain accurate quality records, data analysis, and documentation.
• Conduct internal and external audits as required.
• Represent quality interests during project teams and external audits.

Training and Mentorship:
• Train and mentor junior quality engineers.
• Familiarize yourself with various processes across different product lines.

Qualifications and Skills:

Education and Experience:
• Hold a Level 8 or equivalent degree in Quality Assurance or a related discipline.
• Possess a minimum of 3 years’ experience in a Quality Engineering role, preferably with active involvement on a manufacturing floor, especially within the medical device sector.

Work Ethic and Teamwork:
• Operate guided by the principles of due diligence and compliance in all work aspects.
• Demonstrate commitment to being a valuable team member, striving to achieve best practices aligned with department and site objectives.

Communication and Collaboration:
• Communicate effectively and influence across multi-functional teams.
• Manage internal and external customers’ requirements.

Technical Proficiency:
• Be proficient in Microsoft Office.
• Familiarity with Syspro, Minitab, and Lotus Notes is desirable.
• Understand ISO 13485, ISO 14971, and QSR 21 CFR Part 820 standards.

Interpersonal Skills and Adaptability:
• Exhibit excellent interpersonal skills.
• Collaborate effectively in cross-functional teams.

Analytical Abilities:
• Demonstrate strong proficiency in statistical analysis techniques for investigating and solving problems, ultimately improving quality.

Time Management and Project Completion:
• Plan, organize, and prioritize daily work routines to meet established schedules.
• Drive projects to successful completion.

Advantageous Skills:
• Having received Project Management training is advantageous.

For more information surrounding the role, feel free to contact Kirsty on .

INFORM3 Recruitment is an equal opportunities employer. By applying to this position, you accept the terms of our privacy policy which you can find on our website.

Skills:
Pharma pharmaceutical Quality Assurance
Roscommon Ireland

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