Senior Quality Engineer (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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Grecia, Costa Rica

Job Description:

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

We are searching for the best talent for Senior Quality Engineer to be in Grecia, Costa Rica.

Purpose:

The Senior Quality Engineer will provide support for installation, qualification and day-to-day sustaining activities for orthopeadic implant and instrument 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 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 qualification 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. 


* 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 ...