Quality Systems Specialist Selling Units
Leica Microsystems
Milano, Lombardia, Italy
1 gg fa

About UsLeica Microsystems is a world leader in microscopes and scientific instruments. Founded as a family business in the nineteenth century, the company’s history was marked by unparalleled innovation on its way to becoming a global enterprise.

Its historically close cooperation with the scientific community is the key to Leica Microsystems’ tradition of innovation, which draws on users’ ideas and creates solutions tailored to their requirements.

At the global level, Leica Microsystems is organized in three divisions, all of which are among the leaders in their respective fields : the Life Science Division, Industry Division, and Medical Division.

Leica Microsystems has seven major plants and product development sites around the world. The company is represented in over 100 countries, has sales and service organizations in 20 countries, and an international network of distribution partners.

Its headquarters are located in Wetzlar, Germany. Leica Microsystems, Inc offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives.

Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Leica Microsystems, Inc.

is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

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Description

Responsible to maintain the existing Quality Management System (QMS) according to the standards and regulations (ISO13485, ISO9001, ISO14001) for Leica Microsystems (LMS) Selling Unit (SU) offices in Europe (Italy, France, Spain and UK).

The Quality System (QS) Specialist will support the EMEA functional SU teams to maintain compliance with the QMS processes, further interacting directly with 3rd party auditors during site assessments, providing overall leadership to the functional levels and support for all regulatory and quality assurance (RA / QA) related issues at SU side.

Responsible to coordinate post market surveillance (PMS) activities like recall or field corrective actions in cooperation with the respective Business Units and supports the business units in regulatory registration activities in EMEA region.

The QS Specialist will make recommendations for the continuous improvement of QMS processes and directs resources in support of Key Performance Indicators (KPI) and other metrics.

Responsible to verify effectiveness of QMS by internal audits.

KEY RESPONSIBILITIES

QUALITY MANAGEMENT SYSTEM :

  • Maintain and improve QMS
  • Drive continuous improvement of QMS
  • Support QMS harmonization effort within LMS
  • AUDITS (External and internal)

  • Primary point of contact for external audits
  • Performing and / or overseeing internal QMS Audits
  • TRAINING AND GUIDANCE

  • Perform and / or oversee QMS trainings
  • PMS :

  • Coordinating RA / QA related activities in on Selling Unit side (direct interaction with RA / QA staff from BU)
  • Supporting Field Corrective Actions (reportable and non-reportable) on Selling Unit side (interface to BU)
  • VOC (Voice of Customer)
  • Supporting customer related quality issues (interface to BU)
  • Recall Coordination
  • Supporting Registration / Submission activities in EMEA
  • Qualifications

    REQUIREMENTS FOR THIS POSITION

    Professional Experience

    Minimum 2-3 years proven QMS, RA and / or QA experience in Automotive, Medical, Life Science or Industry or equivalent combination of education and experience.

    Experience in FDA-regulated industry is a plus.

    International experience in problem solving, complaint handling or equivalent

    Education

    Bachelor's degree (BA / BS) from four-year college or university required.

    BSc degree or equivalent in science, engineering or equivalent

    Knowledge of US and EU medical device regulatory requirements

    preferably German

    Travel (required estimated % of time)

    Strong quality focus.

    Independent working approach

    Passion for an effective QMS as the foundation of high quality products and services.

    Hands on mentality in combination with solution oriented mind-set.

    Ability to communicate across all levels within the organization.

    Strong analytical and organizational skills; ability for detail and precision.

    Team player with ability to work alone

    Strong problem solving skills

    Well organized, able to prioritize, ability to see the bigger picture

    High levels of integrity

    Experience in holding presentations and trainings

    Danaher Corporation OverviewDanaher 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.

    Leica Microsystems

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