Engineer I, Quality Validation

Engineer I, Quality Validation (Laboratories), Critical Care (Temporary)

• type Full time
• Location Dominican Republic, Nave 25, Merengue

Apply knowledge of engineering principles and methods to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices for the Cardioband operation.

Key Responsibilities:
• Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, Edwards Lifesciences SOPs and Good Documentation Practices (GDP) Utilize test equipment to verify equipment parameters, process outputs or product outputs. Anticipate risks of execution and put mitigations in place so audit review requirements are met. Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria. Work with cross-functional partners to implement comprehensive preventative maintenance work instruction as well as revalidation requirements. Write Validation Plans for projects that require multiple validations and create timeline for validation.
• Provide daily direction and guidance to manufacturing processes and personnel.

• Review and disposition Non-conformance reports where needed. Assist in Root Cause analysis in order to determine corrective and preventive action activities

• Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions and Device Records
• Evaluate risk, manage risk assessment activities and create associated documentation.
• Investigate and implement solutions to audit findings.
• Lead process improvement projects as part of life cycle approach.
• Other incidental duties assigned by Leadership

Education and Experience:
Bachelor's Degree in in Engineering or related field , at least 1 year years experience of validation within medical device or pharma industry, or related experience, required

Additional Skills:
• Basic understanding of statistical techniques.
• Manufacturing Engineering and/or Process Validation background preferred
• Proven ability to apply Engineering/Scientific theory
• Strong problem-solving, organizational, analytical and critical thinking skills
• Excellent verbal and written communication skills in English.
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• The Validation Engineer will need to be highly flexible and assume multiple engineering roles. As the volume of work expands in Israel, increased specialization of engineering positions will be more practical.
• This engineer will be expected to work closely with coaches and peers in Irvine, to enable the flexible nature of this job.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

 

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring What we offer Diversity, inclusion & belonging

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Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

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