Senior Quality Engineer

Johnson & Johnson; Ringaskiddy; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading healthcare company seeks a Senior Quality Engineer to enhance product quality and compliance. This role requires a Bachelor's in Engineering and significant experience in quality assurance processes, particularly within FDA and European regulations. Join us to make a positive impact in healthcare innovation.

Qualifications

• 4-6 years of proven experience in FDA and European regulatory environments.
• Experience with Statistical, Lean, and Six Sigma methodologies.
• Proficiency in data analysis for decision-making.

Responsibilities

• Lead quality improvement initiatives and analyze processes.
• Ensure compliance with ISO and QSR standards.
• Manage risk assessment and product quality control.

Skills

Problem-solving

Statistical analysis

Lean methodologies

Six Sigma

Education

Bachelor's degree in Engineering or a related technical field

Tools

Statistical software

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

About Us: MedTech

At MedTech, we are driven by innovation at the multifaceted intersection of biology and technology! We are committed to developing the next generation of smarter, less invasive, and more personalized treatments that empower patients on their journey to wellness. Curious about our mission? Learn more at Johnson & Johnson MedTech.

Job Summary

As a Senior Quality Engineer, you'll be at the forefront of engineering perfection, leading projects that require your sophisticated expertise. You will play a crucial role in applying your diverse knowledge of engineering principles to transform our product lifecycle and enhance quality assurance. Your talents will directly supply to groundbreaking healthcare solutions!

Duties & Responsibilities

Business Improvement & Quality Assurance

• Lead quality improvement initiatives through innovative process and product characterizations.
• Analyze and implement tools like PDCA, Six Sigma, and Kaizen to improve quality.
• Conduct benchmarking studies to elevate our quality standards.

Regulatory Standards & Compliance

• Ensure our products and processes align with major standards (ISO 13485, QSRs) and support during audits.
• Champion compliance to guarantee our innovative solutions meet global regulations.

Product Quality Control & Disposition

• Take ownership of material review board activities and handling non-conformances and customer complaints.
• Review root cause investigations and efficiency of corrective actions.

Product & Process Management

• Develop and implement monitoring and control methods tailored to risk levels.
• Complete analytical and statistical analyses to develop process improvements.

Risk Management

• Assess proposed changes in processes to maintain compliance and handle risks effectively.
• Craft and evaluate risk mitigation techniques for our products.

Qualification & Validation

• Oversee the review and approval of critical quality measures, ensuring our manufacturing and testing equipment meet rigorous standards.

Experience & Education

• A Bachelor's degree in Engineering or a related technical field is required.
• 4-6 years of proven experience, ideally in both FDA and European regulatory environments.
• Proven experience with Statistics, Lean, and Six Sigma methodologies is crucial.

Required Knowledge, Skills & Abilities

• Proficiency in statistical software to analyze data for informed decision-making.
• Strong problem-solving skills with a hands-on approach to troubleshooting.
• Comprehensive understanding of GMP/ISO regulations and validation standards.

Why Join Us?

At MedTech, you’ll be part of a hard-working team committed to making a difference in healthcare. If you’re ready to give your outstanding skills to transform patient care, apply now and be part of our exciting journey toward innovation!