SENIOR QUALITY ENGINEER

Johnson & Johnson is currently recruiting for a Senior Quality Engineer! This position will be located in Anasco, Puerto Rico.
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.
nj.
om/.
Position Summary.
Serves as primary Quality Assurance associate, supporting the base business 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 including complete projects requiring advanced knowledge of a specialized field.
Applies comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas and coordinate/direct activities of technical support staff as needed.
Utilizes advanced Quality Engineering tools and practices to support the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
Utilizes advanced 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.
Key Responsibilities.
Business and Quality Systems Improvements 1.
Lead quality improvement initiatives as directed including process and product characterizations that lead to continuous / cost improvements.
2.
Assists Product/Process improvement efforts i.
..
scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by assisting in the appropriated analysis methods to enhance sustaining product design.
3.
Reviews/analyses effectiveness of Six Sigma, Kaizen, Lean Techniques or other improvement tools.
4.
Conducts benchmarking to develop more effective methods for improving quality 5.
Leads the development of quality engineering and quality compliance roles with the right skill sets for existing processes and product life cycle management.
Compliance/Regulatory 6.
Champions compliance to applicable Global Regulations and standards (e.
.
QSRs, ISO, EN and Medical Device Directive requirements) including providing support during internal and external audits.
7.
Reviews/analyses current product and processes (including actions/decisions conducted) to confirm compliance to standards such as QSRs & ISO .
Conducts periodic line audits to assess for production controls.
Reviews results of area audits to ensure that corrective and preventive actions are adequate.
Product Quality, Control & Disposition and Performance Standards 9.
Responsible along with the triage (Mfg Supervisor, Mfg Engineer & Quality Engineer) to evaluate events that may result in nonconformances, generate nonconformance reports, RIA (Risk Impact Assessment) and support the investigation process.
10.
Supports investigations, bounding, impact evaluations, review and approval of NRs, CAPAs and customer complaints and escalates quality issues as appropriate.
11.
Identifies Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions Change Management and Risk Mitigation 12.
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 13.
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 14.
Responsible for reviewing / approving CO’s requiring QE approval as required.
Product/Process Qualification 15.
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.
Production/Process Controls including Control Plans 16.
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.
17.
Provides support to business functions (e.
.
quality, engineering, operations, facilities) on procedural readiness execution and remediation, measuring execution and effectiveness as required.
18.
Leads efforts, together with operations and engineering, to evaluate changes that can result in mix-up, or other risks related to line layout, manufacturing process flows, and/or material flow.
19.
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.
20.
Conducts stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan 21.
Develops measurement systems/capabilities, destructive tests, and/or non-destructive tests for manufacturing processes 22.
Develops control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
23.
Develops, interprets and implements appropriate process monitoring and control methods consistent with the level of process/product risk.
24.
Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
25.
Develops, interprets and implements standard and non-standard sampling plans 26.
Assesses effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
27.
Is accountable for ownership of sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
28.
Assesses and interprets common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
Strategic 29.
Ensures effective quality strategies are created for the validation of test methods, process and design Qualifications Education.
A minimum of a Bachelor’s or equivalent University degree is required with a focus in Engineering preferred.
Required.
4-6 years of related experience, as a minimum on a regulated environment.
Experience working in both an FDA and European regulatory environment is a must.
Relevant quality related experience working in manufacturing/operations.
Experience with a proven track record of implementing appropriate risk mitigation.
In-depth knowledge of product/process Risk Management (FDA and ISO standards) Technical training and intermediate to advanced experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
Ability to perform "hands on" troubleshooting and problem solving Ability to think on the feet and providing sound judgment is highly desired.
Advanced technical understanding of manufacturing equipment and processes • Advanced Process Validation expertise is a must.
Thorough understanding of GMP/ISO regulations and validation regulations Advanced knowledge and proven leadership in the areas listed in the Responsibilities section associated with the position.
Advanced project management and project leadership abilities.
Other.
This position may require up to 10% travel Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.
areers.
nj.
om.