Direct message the job poster from Sigmar Recruitment
Recruitment Manager @ Sigmar Recruitment
About Your New Employer
Join a global leader in medical technology, services, and solutions, dedicated to improving patient outcomes through innovative solutions. You will work on cutting-edge medical devices that comply with international standards, ensuring global reach and influence.
About Your New Job
As the Senior Quality Assurance Engineer you will:
* Ensure products are maintained throughout their lifecycle and comply with global standards.
* Assess patient risk for design changes and provide QA technical direction for qualification and validation activities.
* Generate protocols and compile data for regulatory submissions to support design change approval.
* Work with Regulatory Affairs to present information clearly and minimize agency questions.
* Establish strong relationships across the organization and with partners in a complex technical environment.
* Maintain up-to-date knowledge of regulatory compliance for product design, development, and commercialization.
* Collaborate with engineering and manufacturing to ensure quality standards, conduct tests, and perform statistical analysis.
* May focus on design, material, production control, product evaluation, reliability, inventory control, or R&D as they apply to quality.
* Understand and apply risk management concepts to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
What Skills You Need
* Regulatory Knowledge: Expertise in FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
* Technical Direction: Ability to provide QA technical input for qualification and validation activities.
* Design Verification: Experience in generating protocols and compiling data for regulatory submissions.
* Cross-Functional Collaboration: Strong ability to work across various functions and establish effective relationships.
* Quality Assurance: Proficiency in conducting quality assurance tests and performing statistical analysis.
What’s on Offer
* Attractive compensation package.
* Opportunities for continuous learning and growth.
* Work on products that make a difference worldwide.
What’s Next
Apply now by clicking the “Apply Now" button
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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