Quality Engineer II (SEGUNDO TURNO)
- Ciudad Juárez, Chih.
- Permanente
- Tiempo completo
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Ciudad Juarez, Chihuahua, MexicoJob Description:This position is related to support I-Prevent improvement projects and active participation during MES implementation.Impact: Unable to achieve the goals and Objectives committed during 2025Share point Request ID: 240About MedTechFueled 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/medtechAbout CardiovascularFueled 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtechWe are searching for the best talent for QUALITY ENGINEER II to be in Ciudad Juarez, Mexico.RESPONSABILITIES:In accordance with all applicable federal, state and local laws/regulations and CorporateJohnson & Johnson, procedures and guidelines, this position:o Primary responsibilities include assisting in a supporting role on new product development,sustaining and supply chain quality projects. Assist in the development of effective qualitycontrol and associated risk management plans.o Write process and product validation protocols and reports, equipment qualifications,engineering change orders.o Use statistical tools to analyze data, make acceptance decisions, and improve processcapability (Six Sigma, SPC, DOE).o Help to ensure that development activities follow design control requirements, product is testedper applicable standards, European Essential Requirements are met per the MDR, and productis properly transferred to manufacturing.o Provide support in quality improvement opportunities as appropriate to legacy products,continuous improvement, and customer satisfactiono Assist in planning necessary to ensure effective product acceptance. This includes, but is notlimited to, inspection instructions, equipment and gage requirements, and sampling plans.o Support vendor audits as technical lead as needed and support Supplier Quality as FranchiseQuality representative as appropriate.o Support NC, CAPA, Internal Audit, Training and QS activities as needed and ensurescompliance to all applicable due dates.o Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.o Assist in complaint analysis as appropriate.o Assist Regulatory Affairs in developing submissions for process changes, inspection changes,and new processes/devices as necessary.o Moderate exercise of judgment is required on details of work and in making selections andadaptations of engineering alternatives.o Supervisor or Sr./Staff/PMgr screens assignments for unusual or difficult problems and reviewstechniques and procedures to be applied on non-routine work.o Receives general direction on new aspects of assignments.o Performs work which involves conventional types of plans, investigations, surveys, structures, orequipment with relatively few complex features for which there are precedents.o Responsible for communicating business related issues or opportunities to next managementlevel.o Responsible for ensuring subordinates, if applicable, follow all Company guidelines related toHealth, Safety and Environmental practices and that all resources needed to do so are availableand in good condition.o Responsible for ensuring personal and Company compliance with all Federal, State, local andCompany regulations, policies, and procedures.o Performs other duties assigned as needed.o Responsible for communicating business related issues or opportunities to next managementlevelo Responsible for following all Company guidelines related to Health, Safety and Environmentalpractices as applicable.o For those who supervise or manage a staff, responsible for ensuring that subordinates follow allCompany guidelines related to Health, Safety and Environmental practices and that allresources needed to do so are available and in good condition, if applicableo Responsible for ensuring personal and Company compliance with all Federal, State, local andCompany regulations, policies, and procedureso Performs other duties assigned as neededEXPERIENCE/ EDUCATION/ QUALIFICATIONS:
- Bachelor’s degree in a related field, along with minimum 2 – 4 years of quality, manufacturing, or
- research and development experience in a medical device or other regulated industry is required.
- Master’s degree is preferred.
- Bilingual: English / Spanish, preferably.
- American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
- Familiarity of GD&T (Geometric Dimensioning and Tolerancing) concepts is desirable.
- Ability to develop and implement Quality standards.
- Some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
- Some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
- Ability to apply project management skills to fulfill new product development requirements.
- Problem solving skills.
- Verbal and written communication skills and ability to effectively communicate with internal and external personnel
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