Quality Eng II

Recruiter: Francisco Munoz Munoz

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

About the role:

Provide Process/Quality Engineering support to manufacturing or new product development teams, helping to ensure delivery of highest quality products or new products to the customer.

Your Responsibilities Include:

• 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.
• Understanding product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
• 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 prevalent tools used and by reviewing & utilizing available training materials.
• Checks and provide support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Get involved 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.
• Read and interpret technical drawings, procedures, and protocols
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Work with Research and Development to efficiently qualify new components; assist suppliers in creating statistical sampling plans, inspection methodology and quality procedures for new components
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Provide supervision, leadership, and overall direction to the Quality Release team to ensure they identify issues, quarantining defective products, and efficiently moving products through the release process. Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOPs.

What we're looking for:

Required Education & Experience

• Bachelor's degree in engineering (Mechanical, Industrial, Biomedical, or related field).
• 2+ years of experience in manufacturing, sustaining engineering, or quality engineering within a regulated industry (medical devices preferred).
• Proven experience with CAPA management, quality systems, and root cause analysis.
• Familiarity with ISO standards, FDA regulations, and Good Manufacturing Practices (GMP).
• Engineer II for supporting the Sustaining process in the Stents area for the Urology Business Unit, on Shift A.
• Responsible for evaluation and ownership of NCEPs and CAPAs, proactive approach, mitigation of quality catches, quality projects and complaint reduction, leader of preventive quality initiatives, VIPS preventive CAPAs.
• Projects with impact at the BU level and Plant level.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication and leadership abilities.

#CRTA #HRDTA

Requisition ID: 620446

As a leader in medical science for more than 40 years, we are committed to solving the challenges that 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.