Convatec · 17 hours ago
Specialist II- Sterilization
FLD-London Remote Workers
Full-time
Remote
Mid Level
3+ years exp
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Responsibilities
The MDR compliance effort related to Sterilization.
Day-to-day support for sterilization procedures and instructions.
Participation in Product Development in terms of determination of sterilizability of the new/altered product design to ensure optimal sterilization.
Participation in Process Development relating to the sterilization process.
Preparation of validation protocols for sterilization processes within the cycles and products related to Infusion Device area. Review of protocols and reports from other business units on request.
Participation in Validation activities on a level to make it possible to review/approve the documents related to the activities such as validation reports.
Preparation of Procedures and Work Instructions within the sterilization area.
Perform or participate in internal and external sterilization/production site audits.
Provide support in connection with product registrations and/or inquiries from authorities and customers, and customer audits.
Support training of QA/QC staff related to release of sterilized products.
Participate in projects to support sterilization, sterility assurance, contamination controls and sterilant residue related projects.
To provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Infusion care manufactured products.
To ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion.
To provide training on the QMS documents applicable for the area of sterilization as appropriate.
To ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided.
Qualification
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Required
Proficiency in MS Office (required).
Fluent in English, both verbally and in writing (required).
Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (required).
Demonstrates knowledge of ethylene oxide and radiation principles and industry standards and experience in sterilization process controls is a must.
Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards.
Preferred
BS in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or min 3 years or more experience if no appropriate science degree.
Lead Auditor (preferred).
Company
Convatec
ConvaTec specializes in the development, manufacture, distribution of single-use devices to hospitals and healthcare sectors. It is a sub-organization of The Amcare™ Group.
5001-10000 employees
H1B Sponsorship
Convatec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.26BKey Investors
Novo Holdings
2017-03-29Post Ipo Equity· $1.26B
2016-10-27IPO
Leadership Team
Karim Bitar
Chief Executive Officer
Divakar Ramakrishnan
Chief Technology Officer
Recent News
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2024-11-12
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2024-11-12
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