Apply knowledge of quality 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 Costa Rica Heart Valve Therapy 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
Collaborate with cross functional teams in Costa Rica, Singapore, Horw, Switzerland and Irvine to implement and align Quality Control inspection plans, requirements, and methodologies.
Provide daily direction and guidance to manufacturing processes and personnel.
Work with production and inspection staff to analyze, evaluate, understand and resolve any assembly inconsistencies or product / production issues.
Review and disposition Non-conformance reports. Perform 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
Establish a Receiving Inspection function including writing and implementing procedures, hiring and supervising Inspection technician to support product and receiving inspections.
Evaluate risk, manage risk assessment activities and create associated documentation
Investigate and implement solutions to audit findings
Manage Supplier Quality activities as needed.
Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action
Evaluate supplier Quality systems, strategies and regulatory compliance via vendor audits
Partner with Suppliers, as appropriate to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet EW and applicable regulatory requirements.
Other incidental duties assigned by Leadership Education and Experience : Bachelor's Degree in Engineering or related field , 4 years years experience of validation, quality 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.
Written and verbal communication skills in Spanish preferred
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 Sr. Quality Engineer will need to be highly flexible and assume multiple engineering roles. As the volume of work expands in Costa Rica, increased specialization of engineering positions will be more practical.
This engineer will be expected to work closely with coaches and peers in Irvine, Singapore and Costa Rica to enable the flexible nature of this job.
Adhere to all EHS rules and requirements 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