- 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.
- Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
- 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
- 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.
- Degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
- Validation and Transfer experience is nice to have
- English Level desired: B2:(80-89%).
- Desired knowledge: Formal Training on statistical and quality techniques desirable, ASQ Certified, Knowledge of Six Sigma, APQP or similar tools.
- At least 5 years of experience in similar position.
- Please Submit CVS in English
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SR, Quality Engineer Cartago - Boston Scientific
Descripción
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:
Additional Skills:
What We're Looking For:
Requisition ID: 577721
matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
Benefits
• Life-Work Integration
• Community
• Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.
