Quality & Compliance Staff Engineer

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

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/

J&J MedTech is recruiting for a Quality & Compliance Staff Engineer reporting to the Quality Operations Manager and to be based in Cork (Ireland).

JOB SUMMARY

The Quality & Compliance Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. 

The Quality & Compliance Staff Engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments.  Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.

The Quality & Compliance Staff Engineer will utilize Quality tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.

The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.

They will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. 

This person will support processes in Base Business and supervise and lead projects and initiatives, as well as lead, mentor and support team members.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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.

Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality.
• Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.

Compliance/Regulatory

• Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation.
• Review results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. 
• Supports the development of quality strategies related to the transfer of products, materials, and components within J&J or externally.  Supports new product introduction as part of design transfer.

People

• Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians)

Product Quality, Control & Disposition and Performance Standards

• Lead and maintain Material Review Board. 
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.  Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. 
• Analyse/review effectiveness of preventive and corrective actions.  Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

Product/Process Qualification

• Approve IQ, OQ, PQ, TMV or Software Validation

Production/Process Controls including Control Plans

• 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.
• Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.
• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes.
• Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. 
• Develop, interpret, and implement standard and non-standard sampling plans.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis. 
• Accountability and ownership for 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.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Risk Mitigation

• Document, justify, review, or analyse whether 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 such as the QSRs.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

Strategic

• Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation.
• Ensures effective quality strategies are created for the validation of test methods, process, and design.

EHS&S

• Actively promote a safety culture.
• Management of tasks and action plans relating to corrective and preventative actions assigned to the team.
• Manage contractors / vendors working on site to ensure full compliance with site safety requirements.

EXPERIENCE AND EDUCATION

• Degree qualified in a relevant Engineering/Science discipline, and/or 5+ years relevant experience in the Medical Device industry or medical field.
• Demonstrated leadership skills and the ability to make effective decisions.
• Experience in regulated industry, FDA, ISO, etc.
• Proven track record of successfully delivering projects.
• Self-motivated, with focus on Quality, Delivery and Cost.
• Previous people management experience
• Certification in Six Sigma or Statistical Engineering.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes is required.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Excellent Planning & Organisational Skills
• Strong project and people management, coaching and leadership skills are desired.
• The ability to perform "hands on" troubleshooting and problem solving is required. 
• The ability to think on the feet and providing sound judgment is highly desired.
• Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem-solving skills.
• Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
• Demonstrated project management and project leadership abilities are required. 
• Flexible work ethic.
• Strong influencing skills.
• Excellent communication and presentation skills.
• Good Problem-Solving skills.
• Drive, energy and enthusiasm for delivering to commitments.
• Excellent planning & organisation skills with an attention for detail.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

LOCATION & TRAVEL REQUIREMENTS              

• This position may require up to 20% travel and will be based in an MD&D manufacturing facility.