Senior Engineer, Quality Assurance-Orthopeadics (Grecia, Costa Rica)

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

Job Description:

"Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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 Orthopedics

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 Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics 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 Senior Engineer, Quality Assurance to support our Orthopedics business in Grecia.

Purpose:

Provide high-performance quality system guidance and support for the development, maintenance, and compliance of the company’s Quality Management System.

The Senior Quality Analyst will work closely with business partners to provide leadership in Quality System standardization activities, ensuring that the site complies with franchise procedures and external standards and regulations.

You will be responsible for:

In accordance with all applicable federal, state, and local laws/regulations, as well as Johnson & Johnson corporate procedures and guidelines, this position:

• Serve as a Quality Systems expert, track and report the status/completion of action plans related to quality system improvement efforts.
• As needed, assist in the creation, modification, and improvement of Quality System procedures, work instructions, and related documentation.
• Drive robust quality and compliance execution across the business and promote success against Q&C scorecard metrics by working closely with key business stakeholders.
• Work on complex investigations, coordinate technical teams, and lead cross-functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification, and validation of CAPAs, Nonconformances, and subsequent investigation closure.
• Oversee all Compliance activities within the facility in partnership with Regulatory Compliance and Quality Operations groups. Act as a liaison with management at all business levels and develop metrics and present data on site performance in forums such as weekly and monthly management meetings.
• Oversee the Customer Complaints system in partnership with the Complaints and Vigilance Manager, ensuring timely closures and full satisfaction of all Customer Complaint requirements.
• Ensure that the Quality System Review (QSR) continues to develop in terms of inputs and that any trends observed in this forum are challenged and acted upon accordingly.
• Be responsible for providing training on Quality Systems Management principles to business partners.
• Facilitate the product issue evaluation process, Quality Review Board preparation, and field action execution.
• Facilitate technical innovations to improve Quality Systems and support business objectives.
• Provide internal support for inspections and third-party audits, such as registrar, notified body, FDA, or customer audits.
• Serve as SME in the Quality Planning process, assist Quality Plan authors with the process, and archive Quality Plans.
• Responsible for communicating business-related issues or opportunities to the next level of management.
• Responsible for following all company guidelines related to health, safety, and environmental practices, as applicable.
• For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources required to do so are available and in good condition, as applicable.
• Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Perform other assigned tasks as necessary.

Qualifications / Requirements:

EXPERIENCE AND EDUCATION

• Minimum required education: Bachelor’s degree, preferably in Engineering, Mathematics, Science, or Business.
• 4–6 years of experience in Quality Systems, Quality Engineering, Quality Assurance, or other equivalent technical experience.
• Minimum of 4+ years of experience in an FDA-regulated industry, such as medical devices, pharmaceuticals, etc.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES

• Working knowledge of 21 CFR Part 820, 21 CFR 806, ISO 13485, and familiarity with ISO 14971.
• Broad technical knowledge and experience working effectively with others across various business areas, including Operations, Quality, R&D, Regulatory Affairs, and Engineering.
• Ability to effectively prioritize and manage multiple activities and responsibilities.
• Excellent business and technical communication skills, including verbal, written, and presentation skills.
• Project Management certification preferred, such as PMI certification, Graduate Certificate in Program Management, etc.
• Proficiency in quality-related statistical applications, such as Minitab.
• American Society for Quality (ASQ) credentials preferred.
• Experience leading teams and change management activities.
• Bilingual in English and Spanish.

On October 14, 2025, Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. 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.

It is anticipated following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by Orthopaedics employment processes, programs, policies, and benefit plans. Details of any planned changes would be provided to you by Orthopaedics at an appropriate time and subject to any necessary consultation processes.”

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)