Sr Supv Quality Turno B

September 13, 2024

Edwards Lifesciences

OTHER

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:

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.

Education and Experience:
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.