Quality Assurance Manager
hace 6 días
Embracing Diversity - Fostering Innovation - Compassionate Care - Global Teamwork - Competitive Spirit - Excellence in Performance
At Boston Scientific, we recognize that diversity is our most valuable asset. We are dedicated to empowering women, supporting the LGBTQ+ community, and creating inclusive opportunities for individuals with disabilities. We believe that your unique perspectives enhance our workplace. As an equal opportunity employer, we warmly invite applications from all qualified individuals, irrespective of their backgrounds. Our Gender Equality Policy underscores our commitment to fairness and equality within our organization.
Hybrid Work Environment:
Boston Scientific offers a hybrid work model that includes both remote and onsite work. You will have the chance to discuss specific arrangements during the interview process.
Role Overview:
Key Responsibilities:
- Strategically plan, coordinate, and implement initiatives aimed at preventing process defects and enhancing overall quality.
- Review and approve documentation, investigations, and other regulatory aspects within the company's quality management system as an alternate representative.
- Provide expert technical support to the Quality department and collaborate with other teams.
- Oversee Quality Engineering functions and activities.
- Deliver training sessions focused on quality technologies.
- Collaborate with corporate teams to implement quality-related projects.
- Develop new procedures and refine existing ones to ensure regulatory compliance.
- Serve as the Subject Matter Expert (SME) for various chapters of the quality system, including adverse event reporting, process controls, validation, and more.
- Support new product and process transfer initiatives.
- Design and implement strategies for process control as needed.
- Facilitate and support Quality Control supervision through Quality Engineers and Supervisors.
- Participate as a core team member in new product transfer processes, representing Quality Assurance.
- Manage NCEP system activities, ensuring timely closure of investigations and continuous improvement.
- Engage in the Product Inquiry Report (PIR) process, ensuring diligent execution and communication of activities.
- Provide guidance in areas such as process validation, software validation, complaint handling, and supplier quality assurance.
Ideal Candidate Profile:
- Bachelor’s degree in Industrial Engineering or a related field.
- Proficient in English, with a desired level of C1 (90-94%).
- Knowledge of statistical and quality techniques, with ASQ certification preferred; familiarity with Six Sigma, Lean, APQP, or similar methodologies is advantageous.
- Experience in managing regulatory compliance and handling complaints.
- Proven experience in team management is essential.
- A minimum of 7 years in a similar role is required.
About Us:
As a leader in medical innovation for over four decades, Boston Scientific is dedicated to addressing the most pressing challenges in healthcare. Our mission to advance science for life is centered on transforming lives through innovative medical solutions that enhance patient outcomes, create value for our customers, and support our employees and communities. We are committed to applying our values to every aspect of our work as a global entity and responsible corporate citizen.
At Boston Scientific, you will find a collaborative culture fueled by a passion for innovation. With determination, creativity, and a deep commitment to human life, we are tackling some of the most significant challenges in the healthcare industry. Join us in making a meaningful impact on lives around the world.
Benefits:
• Work-Life Balance
• Community Engagement
• Professional Development
At Boston Scientific, you will be part of a team that is driven by a shared passion for innovation and a commitment to improving lives through your work.
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