Senior Quality Engineer

**Job Function**:
Supply Chain Engineering

**Job Sub**Function**:
Quality Engineering

**Job Category**:
Scientific/Technology

**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, Mexico

Identifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements. Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions. Examines capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements. Performs process validations on current and new Quality Engineering processes for subsequent operational integration and supply chain implementation. Facilitates supervision of Quality Engineering Technicians by supporting and enforcing site-specific safety and industrial hygiene requirements. Communicates and escalates in a timely manner, any Quality Engineering issues or concerns to the next management level. Coaches more junior colleagues in techniques, processes, and responsibilities.Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

**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 Cardiovascular**

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 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.

**We are searching for the best talent for SENIOR QUALITY ENGINEER**

**to be in Ciudad Juarez, Mexico.**

**PURPOSE**:
Participate in new 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. Drive quality assurance activities intended to ensure

effective product quality processes are in place and executed throughout lifecycle of product. May

receive technical guidance on complex problems, but independently determines and develops

approaches and solutions. Shares technical expertise with others and helps develop junior level

engineersCoaches more junior colleagues in techniques, processes, and responsibilities.

**RESPONSABILITIES**:
Under general direction and in accordance with all applicable federal, state, and local laws/regulations

and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Primary responsibilities include working in Quality Engineering and with other functional groups

in support of new product/process development, quality operations or quality assurance.
- Utilizing Quality Engineering tools/processes in development and implementation of practices for

the effective and efficient development, transfer, and maintenance of products/processes

throughout the product lifecycle.
- Leading efforts with quality improvement opportunities as appropriate to legacy products,

continuous improvement, and customer satisfaction.
- Develop and establish effective quality control and support associated risk management plans.
- Write, review and/or approve process and product validation protocols and reports, equipment

qualifications, engineering change orders.
- Use statistical tools to analyze data, make acceptance decisions, and improve process

capability (Six Sigma, SPC, DOE).
- Determine sterility, biological and packaging test requirements utilizing appropriate industry or

agency standards for new products.
- Ensure 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.
- Provide all planning necessary to ensure effective product acceptance. This includes, but is not

limited to, part qualifications, specification development, and sampling plans.
- Support vendor audits as technical lead as needed and support Supplier Quality as Quality

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