Quality Engineering

Position Summary:

Reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high-quality standards for the product manufacturing process and the compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance during the design, development, enhancement, revision and implementation of the quality systems for the efficient manufacturing of products and processes. Provide support and expertise on problem solving, process improvements and in the usage of quality tools. Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, and Sampling Plan Development and Review. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Plant level.

Key Responsibilities:

• Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.).

• Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.

• Supports Operations in the generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans to run base business.

• Lead and/or support Plant Initiatives and/or special projects.

• Supports/initiates investigations of non-conformances (such as but not limited to NCR, CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.

• Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.

• Performs other tasks as assigned by the Quality Operations Lead, Quality Operations Leader or and/or Site Quality Lead.

• Develop, write and approve as required policies, procedures, test methods, specifications.

• Support the Plant Sterilization processes.

• Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes. Facilitate the design transfer process between corporate and plant environments.

• Conduct internal audits and external (supplier, contractor, contract laboratory) audits, in QSR’s and ISO9000, as well as assessments of technical, engineering, operations, & quality related areas.

• Approve and support the control and disposition of non-conformance material as per applicable procedures.

• Perform product impact assessments and the determination of non-conformances scope (i.e. bounding).

• Attend and support Operation meetings.

• Support manufacturing in the day-to-day troubleshooting situations and actively participates on Integrated Production Team’s (IPT).

• Acts as a designated Quality Operations Lead or Quality Operations Leader when needed. · Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)

• Responsible for communicating business related issues or opportunities to next management level.

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University degree is required with a preferred focus in Engineering or Applied Science.

Required Skills & Capabilities:

• A minimum of 2 years of work experience with a minimum of one (1) years of related experience in a regulated industry is required; Medical Device experience is preferred.

• Intermediate or higher computer skills and use of software application(s).

• Fully bilingual (Spanish & English)

• EIT, PE License preferred.

• Knowledge of QSR and ISO Standards.

Other:

• Availability to work various schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays, as needed.

• This position may require up to 10% domestic travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.