Costa Rica Job Openings
Edwards Lifesciences
Sr Supv Quality Turno B
FULL TIME
September 13, 2024
Apply knowledge of quality engineering principles and methods to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, supervise employees responsible for quality inspection, supplier quality and continuous improvement for Class III medical devices for the Costa Rica operation.
Key Responsibilities:
Bachelor's Degree in Industrial Engineering or Scientific field, more than 4 years experience of validation, quality within medical device or pharma industry, or related experience Required
Schedule Monday to Friday 03:30pm - 10:30pm
Additional Skills:
Key Responsibilities:
- Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality/technical knowledge of 2 or more production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues
- Ensure that manufacturing processes are compliant with the quality systems requirements and apply engineering tools to ensure process are adequately controlled and collaborates with other departments in the resolution of issues and improvement activities
- 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
- Establish a Receiving Inspection function including writing and implementing procedures and sampling methods, optimize receiving process align with regulatory requirements. Manage Supplier Quality activities as needed, performing supplier evaluations including on-site audits to assess supplier capabilities, regulatory compliance, determine approval status, and verify corrective action and 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
- Partner with engineering or support areas on investigations and/or corrective actions, perform non‐conformance investigations for review with engineering, assures documentation content is valid, may participate in improvement projects
- Support activities related to the evaluation of product risks for non‐compliant distributed products.
- Develop and support ongoing improvement activities to improve Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen Lean methods, DOE, etc
- Other incidental duties assigned by Leadership.
- Strong Knowledge with as CAPA owner and NCR management.
- Experience on internal and External Audits.
Bachelor's Degree in Industrial Engineering or Scientific field, more than 4 years experience of validation, quality within medical device or pharma industry, or related experience Required
Schedule Monday to Friday 03:30pm - 10:30pm
Additional Skills:
- Basic understanding of statistical techniques.
- Manufacturing Engineering and/or Process Validation background preferred
- Proven ability to apply Engineering/Scientific theory
- Ability to lead teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
- Strong problem-solving, organizational, analytical and critical thinking skills
- Excellent verbal and written communication skills in English advanced.(Required)
- 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
- Travel (day and overnight by car, air, train, etc.) will vary. Percentage of time is determined by Management
- May represent the organization to outside contacts, e.g., vendors, suppliers, contractors, staffing agencies
- 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.
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