Ingeniero de Calidad II - Tercer Turno

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:

Ciudad Juarez, Chihuahua, Mexico, MX301 – Circuito Interior Norte - BWI

Job Description:

Purpose:

Under general supervision, participate in new and sustaining product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Supports quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Will receive technical guidance on complex problems, but independently develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion.

You will be responsible for:

• Assisting in a supporting role on new product development, sustaining and supply chain quality projects.
• Writing process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Using statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
• Ensuring that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.
• Providing support in quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction.
• Assisting in planning necessary to ensure effective product acceptance, including inspection instructions, equipment and gage requirements, and sampling plans.
• Supporting vendor audits as technical lead and Supplier Quality as Franchise Quality representative as appropriate.
• Supporting NC, CAPA, Internal Audit, Training and QS activities as needed and ensuring compliance to all applicable due dates.
• Initiating and investigating Corrective and Preventative Actions (CAPA) as appropriate.
• Assisting in complaint analysis.
• Assisting Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
• Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
• Receiving general direction on new aspects of assignments.
• Performing work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.
• Communicating business-related issues or opportunities to the next management level.
• Ensuring compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performing other duties as assigned.

Qualifications / Requirements:

• 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.
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
• Familiarity with 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.