*job function*:
quality
*job sub*function*:
quality assurance
*job category*:
professional
*all job posting locations*:
ciudad juarez, chihuahua, mexico
*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.
*about surgery*
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 surgery? Ready to join a team that’s reimagining how we heal? Our surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
*we are searching for the best talent for staff quality engineer to be in*cd. Juarez in plant independencia*.*
*purpose*:
develops standard operating procedures, specifications, and provides technical transfer and validation support. Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation. Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures. Provides data and documentation in support of the development of validation strategies. Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products. Provides sampling plans and approves inspection methods for evaluation and testing of components and products. Provides support and expertise in reliability planning and reliability growth demonstration during new product development.
*you will be responsible for*:
the quality engineer utilizes quality engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize quality engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall quality requirements and business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
*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 with external companies or internal sites to develop more effective methods for improving quality
- supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
*compliance/regulatory*
- review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the qsrs, iso 13485, etc.
- champions 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.
- 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.
*new product/process introduction*
- supports the development of quality strategies related to the transfer of products, materials and components within j&j or externally. Supports new product introduction as part of design transfer.
*people*
- as applicable, provides supervision, mentoring, coaching, performance review, and developmental plans for others
*product quality, control & disposition and performance standards*
- conduct investigation, bounding, documentation, review and approval of nonconformances, 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.
- accountability and ownership of quality metrics including maintenance and reviewing of leading and lagging indicators of quality
- product/process qualification
- approve iq, oq, pq, tmv or software validation
*production/process controls including control plans*
- conduct stakeholder analysis to ensure that customer ctqs are known and adequately addressed in control plan
- develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing p