Quality Engineer

Company: Pall
Location: Duncan
Posted on: March 16, 2023

Job Description:

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Position Overview

The Quality Engineer is leading quality investigations, keeping oversight of quality complaints (internal and external) and managing the metrics and KPI (Q OBEYA) related to this. The person in this role will maintain the overview of the validated state of products, processes, methods, and equipment. He / She is handling deviations of any kind. Other responsibilities will including being the Quality Lead in plant wide projects and staying closely engaged in R&D projects towards introduction of new products as quality lead.

What you'll do

• Support/lead ME/PE to implement/maintain, as a team member, Process flow charts, Process Control Plans, Process FMEA, validations
• Support transfer from NPI to high volume manufacturing and develop quality control plans
• Responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims
• Coordinate validation activities & development of analysis methods and control plans
• Manage CAPA/POR/NCRs/Complaints processes; ensure root cause analysis and effectively implement robust CAPA. Follow-up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner.
• Manage and maintain overview of all external customer complaints (Daily management in OBEYA PPM reduction)
• Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes. Support shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT&R, VOP, DRS, PSP, FMEA- utilize DBS to drive continuous improvements
• Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement improvements based on the trends
• Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing/Sourcing departments to select/maintain/drop suppliers list based on their performance
• Support Quality Management System (QMS) to meet ISO 9001 requirements; identify and implement/maintain specific standards to the QMS
• Perform Internal Audits per the annual audit schedule, prepare report, follow-up, and verification of completion of actions initiated from audit(s)
• Works closely with Sales, R&D, and Manufacturing to optimize the company's products and relationships with our customers including technical presentations at Customer sites
• Adhere to corporate escalation and reporting guidelines Who you are
  • Bachelor's degree in a scientific or engineering field. (bio, biomedical, chemical, pharma, industrial, mechanical)
  • 5-10 years of manufacturing experience or relevant experience
  • Uses analytical mindset, critical thinking, and data analysis to solve problems creatively and pragmatically, comes up with solutions
  • Gives guidance to more junior team members, shares experiences
  • Understands and has knowledge of the multiple functions within the quality team (can work cross functional)
  • Can make straight forward decisions based upon data analysis, own risk assessment, precedents and procedures
  • Can work independent as a quality lead within a team of R&D and product engineers to support successful implementation of new projects and products
  • Software skills: Proficiency Excel (statistical) and all other Microsoft Office Tools, Minitab, SAP, ERP system and LIMS are a plus
  • Knowledge of Six Sigma tools
  • Ability to travel 5-15% (domestic and international)
  • Excellent communication skills. Fluent in English and other languages are a plus
  • Is aware of and appropriately uses Problem Solving and Risk Assessment tools (5 Whys, PSP, RCA, FMEA)
  • Is engaged and taking initiatives towards continuous improvement. Pro-actively makes recommendations, plans, and implement projects for future improvements
  • Able to work in team and influence others
  • ISO9001:15 Internal Audit Certification a plus
    
    When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
    
    Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
    
    The EEO posters are available here.
    
    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.
    
    If you've ever wondered what's within you, there's no better time to find out.
    
    When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
    
    Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
    
    The EEO posters are available here.
    
    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
    
    If you've ever wondered what's within you, there's no better time to find out.

Keywords: Pall, Gastonia , Quality Engineer, Engineering , Duncan, North Carolina