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Quality Assurance Engineer II
hace 2 meses
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we understand that fostering a diverse and inclusive workplace is crucial for driving innovation and is essential in our mission to advance science for life and enhance patient health. We advocate for inclusion, equality, and opportunity for everyone. By embracing the richness of our diverse backgrounds and perspectives, we create a more rewarding environment for our employees, reflecting the patients, customers, and communities we serve. Boston Scientific proudly stands as an equal opportunity and affirmative action employer, recognized with the Catalyst Award in 2022 for excellence in diversity, equity, and inclusion. Additionally, we uphold a Gender Equality Policy to reinforce our commitment.
Hybrid Work Environment:
Boston Scientific offers a hybrid work model that includes both remote and onsite work. Details can be discussed during the interview process.
Role Overview:
Provide Process and Quality Engineering support to manufacturing or new product development teams, ensuring the delivery of top-quality products or new innovations to our customers.
Key Responsibilities:
- Identify manufacturing process defects (scrap, nonconforming materials, customer complaints) by assessing non-conforming materials, assisting in identifying primary root causes, and understanding corrective and preventive actions. Collaborate with process owners to establish product stops and document release criteria.
- Gain an understanding of product quality plans, documents, and systems by reviewing product specifications, quality specifications, and engaging with quality systems. Learn risk analyses and PRAs.
- Monitor systems by familiarizing yourself with system applications and critical process steps, as well as methods used to minimize process variation.
- Engage in product and process improvement initiatives by analyzing current quality metric data and learning various analysis methods to enhance sustaining product design and new product development.
- Acquire knowledge of Quality Tools & Training Materials by reviewing and utilizing available training resources.
- Support the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
- Evaluate new equipment and processes and participate in the transfer of new products.
- Participate in various stages of equipment and process validations: run, review, and approve reports for I.Q's, O.Q's, and P.Q's, along with any other validation-related documents.
- Interpret technical drawings, procedures, and protocols.
- Ensure all laboratory equipment is compliant for analysis activities (calibration, safety, cleanliness).
- Collaborate with Research and Development to efficiently qualify new components; assist suppliers in developing statistical sampling plans, inspection methodologies, and quality procedures for new components.
- Review and develop process validation protocols and reports. Support other functional areas during validation activities.
- Provide supervision, leadership, and overall direction to the Quality Techs team, ensuring they identify issues, quarantine defective products, and efficiently manage product release processes. Clarify priorities and eliminate roadblocks to maintain high-quality standards in accordance with ISO standards, cGMP's, and corporate and site-level SOP's.
Qualifications:
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field.
- English proficiency: B2 (80-89%).
- Desired knowledge: ASQ certification (CQE, SSGB) preferred, formal education in process and product validation is advantageous, along with a thorough understanding of inspection techniques and statistical methods, and scientific tools (e.g., Gage R&R, DOE, process capability, knowledge in packaging).
- Availability to work in shift B.
- A minimum of 2 years of experience in a similar role.
About Boston Scientific:
As a leader in medical science for over 40 years, we are dedicated to addressing the most significant challenges—united by a profound commitment to human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that enhance patient outcomes, create value for our customers, and support our employees and the communities we serve.
Benefits:
• Life-Work Integration
• Community Engagement
• Career Development Opportunities
At Boston Scientific, you will discover a collaborative culture fueled by a passion for innovation that connects us on a fundamental level. With determination, creativity, and a deep commitment to human life, we are tackling some of the most pressing challenges in the healthcare industry. Together, we form a global team dedicated to making a difference in people's lives worldwide. This is a place where you can find a career with meaningful purpose—improving lives through your professional endeavors.
