Job Description

The Role

Responsible to maintain the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems (LMS and LBS divisions) Commercial Offices (CO) in APAC region.

Your key responsibilities will include, and not limited to:

• Supports the APAC functional CO 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 CO side.
• 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.
• Manage as admin the QMS platform for creation of quality documents and quality trainings
• Responsible for product registration activities in APAC region where required. Maintain a positive relationship with relevant government and regulatory authorities. Support the APAC regulatory team in their registration activities
• Responsible to coordinate post market surveillance (PMS) activities like adverse event/complaint, recall/field corrective actions in cooperation with the respective Business Units.
• Validation of processes impacting on the QMS as needed.

QUALITY MANAGEMENT SYSTEM:

• Maintain and continuous improve QMS
• Support QMS harmonization effort within LMS
• Support any departmental CAPA or non-conformance activities

ENVIRONMENTAL MANAGEMENT SYSTEM:

• Develop environmental objectives and processes where applicable
• Monitor overall environmental management system performance
• Assure fulfillment of compliance obligations
• Promote continuous improvement
• Review the operation of the environmental management system

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 training for: LMS and LBS SU internal employees Sales, Service Customer Care and other departments in the regions as needed
• Analyze, evaluate any applicable new/revised regulatory requirements in APAC market and explain/provide training to relevant stakeholders RA activities
• Drive product registration activities in ANZ/APAC region and in other areas as requested
• Maintain LMS products in ARTG and Medsafe database
• Communicate with TGA and other government agencies and regulatory authorities as appropriate
• Ensure compliance of LMS marketing material with TGA and other local advertising guidelines
• Support IT department in their Master Validation Plan

PMS:

• Coordinating RA/QA related activities (recall, field corrective action, adverse event) on Selling Unit side (direct interaction with RA/QA staff from BU)
• VOC (Voice of Customer)
• Supporting customer related quality issues (interface to BU)

To be successful in this opportunity, a prior experience in the following criteria would be required:

a) Professional Experience

• Minimum 2-3 years proven QMS and/or RA experience in the Regulated Industry
• International experience in problem solving, complaint handling or equivalent
• Knowledge of Australian medical device regulatory requirements (preferred)
• Knowledge of APAC region regulatory requirements (preferred)

b)Education

• Bachelor\'s degree (BA/BS) from four-year college or university required.
• BSc degree or equivalent in science, engineering or equivalent (preferably)

c)Language

• English

d)Travel (required estimated % of time)

• Around 25%

Highly Desirable capabilities:

• Strong quality focus.
• Independent working approach
• Experience in developing 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 (preferred)
• 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

When you join us, you\xe2\x80\x99ll also be joining Danaher\xe2\x80\x99s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\xe2\x80\x99ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

At Danaher, 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.

If you\xe2\x80\x99ve ever wondered what\xe2\x80\x99s within you, there\xe2\x80\x99s no better time to find out.

Danaher