Quality Systems Engineer - Eu Mdr Job In Brisbane, California, Katalyst Healthcares & Life Sciences

Published 2022-08-10
Expires 2022-09-10
ID #1121186596
Quality Systems Engineer - Eu Mdr Job In Brisbane, California, Katalyst Healthcares & Life Sciences
United States, California, Brisbane,
Published August 10, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Quality systems engineer - eu mdr

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Ensure Cutera Quality System conforms to 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP and all other applicable regulatory requirements.

Develop and update Standard Operating Procedures (SOPs), Forms and Templates for the organization.

Work with EU MDR inter-departmental core team to develop and maintain records for EU MDR requirements.

Support the PMS group to update PMS plans, gather post market data and construct Periodic Safety Update Reports for applicable device families.

Analyze, aggregate, and contextualize quarterly data trends to present it to the Quality Review Board.

Collaborate with cross-functional teams and compile data to present during Management Review meetings.

Perform manufacturing audits per audit schedule.

Develop a risk-based internal audit program in the organization.

Support external audits including FDA inspections and notified body audits, as required.

Other duties as assigned.


Bachelor's degree in Science or Engineering or related discipline.

Minimum 2-4 years' experience working in a highly regulated medical device environment.

Strong working knowledge of applicable medical device regulations such as EU MDR, 21 CFR 820, ISO 13485:2016, ISO 14971:2019 and MDSAP.

Lead auditor certification preferred.

Driven team player with the ability to lead multiple projects and activities assigned.

Excellent planning, collaboration, and communication skills.

Proficient in Microsoft Office suite, SPC tools.

Ability to work in a fast-paced, team-oriented environment with strict deadlines.

Significant attention to detail and highly organized.

Demonstrates oral, presentation and technical writing skills.

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    Katalyst Healthcares & Life Sciences
    Registered on October 7, 2017


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    Architecture is both the process and the product of planning, designing, and constructing buildings and other physical structures. Architectural works, in the material form of buildings, are often perceived as cultural symbols and as works of art. Historical civilizations are often identified with their surviving architectural achievements. The term architecture is also used metaphorically to refer to the design of organizations, software, and other abstract concepts. Construction is the process of constructing a building or infrastructure. Construction differs from manufacturing in that manufacturing typically involves mass production of similar items without a designated purchaser, while construction typically takes place on location for a known client. Construction as an industry comprises six to nine percent of the gross domestic product of developed countries. Construction starts with planning, design, and financing; and continues until the project is built and ready for use.

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