Quality And Regulatory Engineer

Cepheid New Port Richey , FL 34652

Posted 3 weeks ago

Quality is King! One of the core values of Pall Corporation is Continuous Improvement (Kaizen) is our way of life. You will participate in a team of like-minded professionals dedicated to driving quality results through a dynamic and structured process. The expectation is to be an integral part of both process controls and solutions. If this sounds like your approach to your career then please read more!

Job Summary:

This critical position is the first line representative of the company when interacting with customers around all Quality related topics. This position works with the Manager of Quality Assurance & Regulatory Affairs, and has reporting responsibility for value stream (product family) Quality Engineers & Quality Technicians.

The ideal candidate for this role, will have aspirations to move into higher levels of Quality and/or Operations management. We are looking to build a strong leadership bench with people that want to have an impact on protecting lives in the air, both in commercial and military aircraft.

This role will require that this individual achieve yearly External (Customer) Quality targets by:

  • Taking responsibility for First Pass Yield and Customer Complaint metrics and drive improvement of both in value stream

  • Being the direct contact for the Quality organizations of a short list of strategic Aerospace customers

  • Implementing and maintaining the Pall Certified Operator Program for assigned value stream

  • Being the leader of Quality Kaizens and Quality Culture in assigned value stream

  • Use a structured and efficient Problem Solving method to achieve sustainable improvements

  • Upgrade and maintain value stream quality system using standard APQP tools (PFMEA and Control Plan) and incorporating them into the Certified Operator Program

  • Work with Engineering and Production to insure safe launches of new products

  • Maintain MRB process and communicate with other value streams regarding internal quality problems

  • Bachelor's degree in technical field, preferably Engineering or Technology

  • At least five years' experience within Operations in a manufacturing environment with a metric and results driven culture, required.

  • Experience with APQP and related tools, including FMEA, Control Plans and PPAP s

  • Use and understanding of SPC and Capability to identify and control process and product variation

  • Solid communication, teaching and leadership skills

Preferred Requirements:

  • Prior Aerospace, Automotive and/or highly-regulated industry experience, highly preferred.

  • Prior experience in supervision / people management or leadership roles

  • Training and use of six sigma tools to drive real improvement

  • Prior experience with customer quality management including customer relationship management, highly preferred.

  • Prior experience with utilizing lean methodology and tools to improve quality and / or overall operations processes, highly preferred.

  • Successful proven use of statistical Design of Experiments and understanding of variation reduction methods

  • ASQ or Six Sigma certifications

Position Competencies:

  • Demonstrated success owning and achieving metric improvement goals through multi-functional project management

  • Leadership, teaching and learning skills

  • Interpersonal Skills and Communication Proficiency

  • Decision-making ability

  • Quality Assurance experience and knowledge of ISO 9001 standards, Quality Systems, PR/MRB (Preliminary Review and Material Review Boards for Non-conforming product), Calibration Systems, engineering drawing interpretation, inspection methodology and metrology, required.

  • Problem Solving using Data collection and analysis

  • Continuous Improvement Mindset using data and a structured approach

  • Compliance and Regulation Focused

  • Cross-functional project management

  • The successful candidate will have a demonstrated track record of quality improvement success in a manufacturing organization within a metric driven, stretch goal environment with yearly improvement goals.

US Citizenship or Resident Alien Status is required to support government programs and projects

Diversity & Inclusion

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page

Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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Quality And Regulatory Engineer

Cepheid