Quality Assurance Specialist
ColoplastAbout the role
Job Summary / Purpose
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The Quality Assurance Specialist is responsible for acting as the local Quality Coordinator
Management representative, supporting the Environmental, Health, Safety and
Quality (EHS&Q) system, applying and maintaining procedures to ensure
quality assurance (QA) and quality control (QC). -
Reporting directly to the Region Director and Head of Quality & EHS.
Essential Duties / Responsibilities
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Lead the quality system as the appointed Management representative.
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Assist in defining and developing quality program status indicators and performance measurements.
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Provide trend analysis on quality issues and performance metrics.
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Lead and support the audit processes including planning, preparation, execution,
reporting results, and remedial work plans. -
Develop and implement internal Quality Control Plans (QCP)
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Ensure QC requirements and QA tasks are completed before the product is shipped.
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Develop, implement and maintain procedures in compliance with the
Environmental, Health, Safety and Quality (EHS&Q) Management System (EHS&Q MS). -
Investigate and address relevant incidents, working with relevant subject matter experts as needed.
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Coordinate deviation and non-conformance processes and ensure corrective and preventive actions
address fundamental causes. -
Create and manage incident reports.
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Provide oversight for compliance of Non-Conformances, Change Controls,
Corrective and Preventative Action, investigations and Out of Specifications. -
Provide training and ensure appropriate competency levels are maintained.
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Ensure compliance to internal and external requirements.
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Continuously improve knowledge of customer expectations and risk management.
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This position may require occasional travel (approximately 10%)
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Shall follow and improve Quality & EHS requirements
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Comply to the relevant elements in section 4.3 of the VV-0113743 Quality Manual
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Comply to relevant elements in section 4.2. of the VV-0113744 Environmental, Health and
Safety Manual
Job Qualifications
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Degree in Economics, Logistics, Engineering or similar
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Minimum 3 years Quality experience including Non-Conformance Management and Quality Control
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Working knowledge of FDA, ISO9001:2015, ISO13485:2016 and ISO14001:2015 preferred
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Highly motivated, detail and results oriented with strong execution, organization, and administrative experience.
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Language: Fluent in English.
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Basic knowledge of using Veeva, MS Office is an advantage.
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Good communication skills and hands-on mentality
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Candidate must be able to work legally in the US without sponsorship.
Competencies & Skills
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Communication skills
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ISO 9001 / ISO 13485
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ISO 45001
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Training defined in the VV-0372933 Global Distribution Training Catalogue
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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, l
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