**Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our compromise.- Hybrid Roles:
- Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.**About the Role**:
- Provide Process/Quality Engineering support to manufacturing or new product development teams, helping to ensure delivery of highest quality product or new products to the customer.**Your Responsibilities Include**:
- Establish a Receiving Inspection function including writing and implementing procedures, hiring and supervising quality inspectors to support product and receiving inspections. Provide quality control support for incoming inspection, in-process and final inspection.
- Write, review and/or approve validation protocols plan and reports (e.g., cleanroom, equipment, test method and product/process transfer validation protocols) in accordance with applicable Regulations, internal procedures. Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation. May be responsible for learning risk analyses and FMEAs.
- Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
- Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.
- Learns Quality Tools & Training Materials by gaining knowledge of tools used.
- Responsible and support in the execution and investigation of CAPAs, NCR, Failure Mode Investigations, etc. 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.
- Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
- Work with production and inspection staff to analyze, evaluate, understand and resolve any assembly inconsistencies or product/production issues.
- Evaluates new equipment and processes and participates in the transfer of new products.Evaluluates the excution of process and product controls.
- Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
- Manage Supplier Quality activities for the site.
- Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action.
- Partner with Suppliers, as appropriate to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet quality and applicable regulatory requirement.
- Collaborate with cross functional teams in Costa Rica, Canada and United States to implement Quality Control plans, requirements, procedures and methodologies.
- Support in internal/external audits (customer and/or notified body)
- Assist Quality Management in implementing, maintaining and aligning quality systems to be compliant with ISO 13485, MDSAP requirements.
- Performs other related duties and responsibilities as assigned by Quality Manager
**Additional Skills**:
- Basic understanding of statistical techniques.
- Manufacturing Engineering and/or Process Validation background preferred
- 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