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Kelly Services NPI Process Engineer in Raynham, Massachusetts

Kelly Engineering Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services is currently seeking a NPI Process Engineer for a long-term engagement at one of our Global clients in Raynham, MA .

Remote 2 days a week and 3 onsite.

This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for 50% paid Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.

As a Process Quality Engineer placed with KellyOCG you will be responsible for the following:

Position Overview: The NPI Process Engineer will actively support new product development as well as front end manufacturing technology and inspection technology feasibility studies. As part of this, this individual will work on small cross functional teams and lead/facilitate planning, conducting and directing engineering projects or studies, including complete projects requiring knowledge of a specialized field. They apply knowledge of engineering principles and practices within assignment areas.

The NPI Process Engineer will utilize Quality Engineering tools and practices for the effective and efficient development 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. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in early phases of development.

Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.

Major Responsibilities & Duties:

Business Improvements

  • Support quality improvement initiatives such as process and product characterizations that lead to cost improvements / cost avoidance.

  • Review/analyze 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 and quality compliance with the right skill sets for new product introductions, and product life cycle management.

Compliance/Regulatory

  • Review/analyze 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 (MD) 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 new product introduction as part of design transfer activities including early process concept development.

  • 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.

  • Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes

  • Develop Components of Variation (COV) studies and any applicable Design of Experiment (DoEs) as required for front end feasibility and process development

  • Explore relevant inspection and manufacturing technologies that meet needs of an NPD project

  • 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.

  • 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 process limits.

Product/Process Qualification

  • Develop appropriate IQ, OQ, PQ, TMV or Software Validation documentation as required.

Risk Mitigation

  • Document, justify, review or analyze 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

  • Ensures effective quality strategies are created for the validation of test methods, process and design.

Qualifications

  • A minimum of a Bachelor’s degree , preferably in Engineering or related technical field. Requires 4-6 years related experience .

  • Experience working in both an FDA and European regulatory environment is preferred.

  • This position will require relevant experience working in manufacturing/operations.

  • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

  • Experience with a proven track record of implementing appropriate risk mitigation.

  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability , etc.

  • Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

  • 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.

  • Good technical understanding of manufacturing equipment and processes is required .

  • 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.

  • 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.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.

( F1 OPT/H1B cannot be considered for this position).

Why Kelly ® ?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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