Senior Quality Engineer

Johnson & Johnson MedTech; Ringaskiddy; On-site; EUR 45,000 - 70,000; Full time

Job summary

A leading company in medical technology seeks a Senior Quality Engineer to drive improvements in healthcare quality. This role involves leading quality assurance initiatives, ensuring compliance with regulatory standards, and applying engineering principles to enhance product lifecycle. Join a passionate team dedicated to healthcare innovation!

Qualifications

• 4-6 years of proven experience in quality assurance.
• Experience in FDA and European regulatory environments.
• Proficient with Lean and Six Sigma methodologies.

Responsibilities

• Lead quality improvement initiatives through innovative process characterizations.
• Ensure compliance with ISO 13485 and QSRs.
• Develop monitoring and control methods tailored to risk levels.

Skills

Problem Solving

Statistical Analysis

Lean Methodology

Six Sigma

Education

Bachelor's degree in Engineering

Tools

Statistical Software

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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!