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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Grecia, Costa Rica

About MedTech

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

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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.

About Orthopaedics

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. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Quality Engineer.

Purpose:
The Analyst, Quality Assurance / Quality Engineer will provide support for installation, qualification and day-to-day sustaining activities for Johnson & Johnson manufacturing processes. They will utilize risk management and problem solving skills to conduct effective technical reviews of the process and ensure quality, safety and efficacy of marketed devices.

You will be responsible for

Under the direction of Quality Engineering Manager and/or Quality Operations leadership, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

New Product / Process Introduction

• Support new product introduction as part of design transfer.

• Support planning and execution of manufacturing process qualifications including IQ, OQ, PQ, Process Verification and Test Method Validation (TMV)
• Ensure that all critical to quality (CTQ) features are identified and adequately addressed in control plan by qualified test methods
• Lead risk management activities and develop process FMEAs to ensure that process risk has been fully assessed, appropriate risk controls implemented, and risk reduced as far as possible

Product Quality, Control & Disposition and Performance Standards

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Assists with documenting critical Quality Assurance issues in product processes.
• Assists with routine collection and dissemination of feedback to ensure continuous improvement of the quality management system.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality

Compliance / Regulatory

• Review/analyze whether current product and processes (including actions or decisions conducted) are complying to standards such as the QSRs, ISO 13485, etc.
• Applies functional knowledge of Quality Assurance best practices and surfaces policies that may impact organizational objectives.
• Follows formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation.
• Review results of area audits to ensure that corrective and preventive actions are adequate.

Other:

• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

Experience and education

• A minimum of a university bachelor’s degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science.
• 0 – 2 years’ experience as a Quality Professional in the Medical Device Industry required.
• Demonstrated knowledge of manufacturing principles and practices, and procedures

Required knowledge, skills, abilities, certifications/licenses and affiliations

Required:

• Good communication skills in English, spoken and written.

• Ability to perform “active involvement” in the solution of problems and resolution of problems, preferably. Capacity to solve problems providing good judgment is highly desired.
• Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis
• Interpersonal skills that foster collaboration relates to technical situations
• Strong initiative and follow-through in completing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or leadership experience

Preferred:

• Experience conducting Process Validation (IQ, OQ, PQ, TMV).
• Experience with inspection & test methods including GD&T
• Experience programing and validating CMM and CNC
• Experience working with ERP systems and associated Quality process flows
• Strong experience with Six Sigma or Lean

• Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus

Required Skills:

Preferred Skills: