Senior Process Quality Engineer

Process Quality Engineer

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness.

As a Process Quality Engineer, you will:

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Support process verification and validation activities
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champion compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports new product introduction as part of design transfer.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Be accountable and have ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop, interpret and implement standard and non-standard sampling plans
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
• BE responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

Qualification / Requirements:

• A minimum of a Degree or equivalent, preferably in Engineering and/or related technical field.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with implementing appropriate risk mitigation strategies.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

Required Experience and Skills:

• Knowledge of statistical software packages is preferred.
• The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and provide sound judgment is highly desired.
• Understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) Process and Process Verification and Validation experience is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

Here's what you can expect:

• Application review: We'll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
• Finally, at the end of the process, we'll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process!

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.