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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Ringaskiddy, Cork, IrelandJob 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?
