Quality Engineer

Job Title: Quality Engineer

Location: DePuy Synthes, Blackpool

Are you passionate about quality engineering and keen to work in the dynamic medical device sector? DePuy Synthes, a leader in the development of innovative medical technologies, is looking for an experienced Quality Engineer to join our team in Blackpool. If you thrive in a fast-paced, high-impact environment and are dedicated to ensuring the highest quality standards, this role is for you!

What You'll Do

As an Engineer in Quality Engineering, you will be part of a committed Quality team, collaborating with the Quality Engineering Team Leader. In this crucial role, you will ensure the ongoing quality and compliance of our manufacturing processes in Base Business. Your work will focus on maintaining and improving the Quality System to meet key regulatory standards including ISO 9000, ISO 13485, FDA QSRs, and the Medical Devices Directive.

Your Key Responsibilities Will Include

• Monthly Trending & Dashboard Reviews: Track and analyze Non-Conformance (NC) data for production processes and generate insights for dashboard reviews.
• Root Cause Analysis & Action Plans: Investigate issues in products or processes, identify root causes, and develop corrective actions to ensure product quality.
• Collaborate with Engineering: Partner with the Engineering team to define, introduce, and optimize new or improved manufacturing processes.
• Validation Master Plan Ownership: Take ownership of the Validation Master Plan and coordinate quality validation reviews.
• Preventive & Corrective Maintenance: Support operations to ensure that maintenance activities are completed to schedule.
• Process Improvement & Lean Manufacturing: Work with teams to ensure compliance in continuous improvement activities, driving Lean Manufacturing initiatives.
• Regulatory Compliance: Ensure consistency to all relevant regulations governing business and quality operations.
  
  

What We're Looking For:

Qualifications

To excel in this role, you will need strong technical expertise and a proven understanding of quality systems and regulatory requirements in a medical device environment.Key qualifications include:

• Education: A minimum of a degree in a scientific field.
• Experience: At least 3 years in a quality, technical, or manufacturing role within a regulated industry.
• Knowledge:
• In-depth knowledge of Good Manufacturing Practices (GMP).
• Familiarity with ISO 13485, FDA QSRs, and validation processes.
• Proficient with Quality Toolbox techniques such as FMEA, root cause investigations, Lean, and Six Sigma.
• Strong analytical and problem-solving skills.
• Excellent interpersonal skills, with the ability to engage optimally across all levels of the organization.
  
  

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.