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|Job Category :
||Katalyst Healthcares & Life Sciences
||Marlborough, MA 01752
|Job Description :
Development of and accountability for Verification and Validation (both Design and Process) test plans, protocols, reports, and test procedures for multi-disciplinary complex energy based (Laser / RF / HIFU) medical aesthetic devices to meet product requirements in accordance with internal company processes and international medical regulations.
Develop and execute TMV activities.
Develop and execute CSV activities.
Represent CSV on software development and deployment teams as the software validation subject matter expert.
Partner with and/or lead business teams and IT to ensure that computerized quality systems are compliant with Candela procedures, FDAs 21CFR11, GAMP 5, and other relevant regulations.
Act as a core team member on software validation projects across Candela.
Monitor/Review/Approve Sterilization work conducted for Candela’s existing and future products by third party vendors and ensure compliance to current Candela procedures, ISO 11135, and ISO 11137 requirements.
Coordinate sterilization qualification for new products and/or changes to existing products.
Partner with Candela’s external vendors on sterilization validation for radiation sterilized products including dose setting and quarterly dose audits.
Partner with Candela’s external vendors on sterilization validation for ethylene oxide sterilized products including but not limited to new product qualification, annual revalidations, residual EO studies.
Ability to define Business Requirements, Functional Specifications, and System Specifications as necessary for software validation projects.
Experience/perspective to establish and enforce a Decision Tree for making Validation Change Assessments, and if Validation is required then how the protocol should be constructed.
Develop and maintain the Candela QMS Validation strategy, Validation Master Plan, Validation Master List, and policies/procedures governing the program.
Monitor process validation, TMVs and support IQ, OQ, PQ and PPQ to ensure strict accordance with requirements.
Identify opportunities for improvement to the V&V QMS.
Report on key performance indicators of Validation System’s effectiveness to Candela Management, including Management Reviews.
Capable of providing site level training as needed to support compliance, sustainability, and system effectiveness.
Other duties as assigned.
Degree in Electrical / Software Engineering or similar related fields.
Ability to create robust documentation and having a strong attention to detail.
2-3 years of experience in V&V under Medical Device and/or Pharmaceutical Regulations.
Experience in an FDA regulated environment that meet internal quality requirements and regulatory standards for Class II medical devices.
Familiarity with FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 60601, ISO 11135, ISO 11137
Familiarity with SW and System automated test tools strong advantage.
Strong Analytical and problem-solving skills.
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