Quality Engineer

Johnson & Johnson•Añasco, PR

6d•Onsite

About The Position

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: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Anasco, Puerto Rico, United States of America Job Description: About Vision 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Quality Engineer to be located in Añasco, PR. Purpose: Serves as primary Quality Assurance associate supporting the day to day manufacturing operations in AMO Puerto Rico Manufacturing, Inc. The individual performing this role will have to create a strong network base with the line supervisor(s), technicians and engineers to address all the opportunities found in the assigned manufacturing line or quality system process. Overall responsibilities include planning, conducting and directing engineering projects or studies requiring general technical knowledge. Applies basic engineering principles and practices within assigned areas. Utilizes basic Quality Engineering tools and practices to support the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. Utilizes basic Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes. Adheres to environmental policy, procedures, and supports department environmental objectives. You will be responsible for: Supports Quality Improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. Assists Product/Process improvement efforts i.e.: scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by assisting in the appropriated analysis methods to enhance sustaining product design Supports the development of quality engineering and quality compliance roles with the right skill sets for existing processes and product life cycle management. Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive requirements) including providing support during internal and external audits. Responsible along with the triage (Manufacturing Supervisor, Manufacturing Engineer & Quality Engineer) to evaluate events that may result in nonconformances, generate nonconformance reports, RIA (Risk Impact Assessment) and support the investigation process. Supports investigations, bounding, impact evaluations, review and approval of NRs, CAPAs and customer complaints and escalates quality issues as appropriate. Identifies Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions. Participates in VRB to document, justify, review or analyze that a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard Assesses the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determines effectiveness of these techniques on previously implemented improvements Responsible for reviewing / approving CO’s requiring QE approval as required. Provides support to the validation and certification of process, test methods, equipment, software, utilities and facilities as required. Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports. Supports the Manufacturing operation in making prompt decisions on product release corrective actions and resolutions of quality problems as well as providing technical assistance. Provides technical consultation of valid sampling plans for inspection and acceptance criteria. Provides support for business functions (e.g. quality, engineering, operations, facilities) on procedural readiness execution and remediation, measuring execution and effectiveness as required. Supports operations and engineering on the evaluation of changes that can result in mix-up, or other risks related to line layout, manufacturing process flows, and/or material flow. Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed. Conducts stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan Supports the development of measurement systems, product quality control plans, process monitoring and control methods by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. Supports analysis of process data and common vs special cause variation to determine effectiveness and adequacy of measurement systems, sampling plans and process limits Strategic Supports the development of quality strategies created for the validation of test methods, process and design. Perform equipment preventive maintenance and validations periodic reviews.

Requirements

A minimum of a bachelor’s degree in engineering is required.
A focus degree in Chemical Engineering is preferred.
A minimum of 2 years of experience in Medical Device or Pharmaceutical industry
Basic project management skills
Excellent written and verbal communication skills in English and Spanish and presentation skills
Team oriented and ability to work effectively with diverse departmental groups
Excellent leadership and problem solving
Computer literate
Basic knowledge of applicable US & non-US applicable regulations and standards (For example 21 CFR 820, ISO13485, European Medical Device Directive)
Basic knowledge and proficiency in the application and principles of Quality Engineering and Validation
Basic statistical knowledge

Responsibilities

Supports Quality Improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Assists Product/Process improvement efforts i.e.: scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by assisting in the appropriated analysis methods to enhance sustaining product design
Supports the development of quality engineering and quality compliance roles with the right skill sets for existing processes and product life cycle management.
Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive requirements) including providing support during internal and external audits.
Responsible along with the triage (Manufacturing Supervisor, Manufacturing Engineer & Quality Engineer) to evaluate events that may result in nonconformances, generate nonconformance reports, RIA (Risk Impact Assessment) and support the investigation process.
Supports investigations, bounding, impact evaluations, review and approval of NRs, CAPAs and customer complaints and escalates quality issues as appropriate.
Identifies Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions.
Participates in VRB to document, justify, review or analyze that a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard
Assesses the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
Determines effectiveness of these techniques on previously implemented improvements
Responsible for reviewing / approving CO’s requiring QE approval as required.
Provides support to the validation and certification of process, test methods, equipment, software, utilities and facilities as required.
Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
Supports the Manufacturing operation in making prompt decisions on product release corrective actions and resolutions of quality problems as well as providing technical assistance.
Provides technical consultation of valid sampling plans for inspection and acceptance criteria.
Provides support for business functions (e.g. quality, engineering, operations, facilities) on procedural readiness execution and remediation, measuring execution and effectiveness as required.
Supports operations and engineering on the evaluation of changes that can result in mix-up, or other risks related to line layout, manufacturing process flows, and/or material flow.
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Conducts stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
Supports the development of measurement systems, product quality control plans, process monitoring and control methods by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
Supports analysis of process data and common vs special cause variation to determine effectiveness and adequacy of measurement systems, sampling plans and process limits Strategic Supports the development of quality strategies created for the validation of test methods, process and design.
Perform equipment preventive maintenance and validations periodic reviews.