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Senior Compliance Officer in Medemblik, Netherlands at Pall

Date Posted: 3/9/2019

Job Snapshot

Job Description

Job ID: LIF004015

About Us

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.

Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.

Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.

Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.

To learn more about Pall, please visit https://www.pall.com/en/about-pall.html.



Description

In this role you will be leading the Customer Audits, handling all Quality Systems questionnaires and responsible for the local Quality System in our global document management system.  Your main areas of responsibility are divided in approximately 30% customer audits and 70% Quality Systems activities.
The Senior Compliance Officer is keeping oversight of quality compliance activities (internal and external) and managing the metrics and KPI (Q OBEYA) related to this. 
He/she maintains the overview of the certified state of products, processes, methods and equipment. He / She is handling deviations of any kind.
The Senior Compliance Officer is the Quality Lead in plant wide compliance projects.

Responsibilities:
  • Host Customer / certification audits:
    • Agree with the customer / certification body on the audit;
    • Plan and prepare the audit;
    • Take care of customer / certification body during the audit;
    • Agree on action plans together with the process owners;
    • Communicate action plans to customer / certification body as a response to the reported non-conformities.
  • Ensure compliance with ISO9001 / ISO13485:
    • Be system administrator in our global document management system (SmartSolve);
    • Review Quality documents;
    • Support in training activities related to SmartTrain;
    • CAPA Management owner;
    • Internal audit owner (schedule and follow-up on execution);
    • Complete Customer Quality Systems questionnaires.
  • Project related activities:
    • ISO9001:2015 / ISO13485:2016 support during implementation;
    • Support SmartTrain implementation;
    • SmartAudit/SmartCAPA implementation.

Job Requirements



Qualifications

Education & Experience:
  • Master's degree in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma,…);
  • Experience: 3+ years;
  • strong working knowledge of quality assurance principles and practices, industry and international regulations and standards;
  • Familiar with ISO9001 and ISO13485, some knowledge of ISO 15378 is an advantage.
Skills & Competencies:
  • Strong verbal and communications skills;
  • Demonstrated cross functional leadership capabilities to assure creation of action plans and achieve on-time results;
  • Ability to multitask, problem solve and decision making;
  • Excellent planning, organizational and presentation skills;
  • Able to use customer feedback to make improvements in process, products and services;
  • Able to work collaboratively across the business;
  • Language: English (written & spoken), Dutch;
  • Computer knowledge: MS Office.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.