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Quality Assurance Manager
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Senior Quality Assurance Manager
hace 2 meses
Commitment to Diversity and Innovation
At Boston Scientific, we embrace diversity as a core strength of our organization. We are dedicated to empowering women, supporting the LGBTQ+ community, and fostering opportunities for individuals with disabilities. Our belief is that diversity enhances our workplace culture. As an equal opportunity employer, we welcome applications from all qualified candidates, regardless of their backgrounds. Our Gender Equality Policy reflects our commitment to fairness and equality in the workplace.
About the Position:
The Senior Quality Assurance Manager plays a pivotal role in designing, planning, coordinating, and executing initiatives aimed at enhancing quality within our manufacturing processes. This position provides essential support to the Process Quality and Quality Engineering teams. The manager is responsible for establishing and maintaining Quality Management systems that comply with regulatory standards, corporate policies, and internal requirements. Furthermore, this role involves overseeing the functions and activities of In Process Quality Engineers.
Key Responsibilities:
- Oversee the functions and activities of Quality Engineering and In Process Quality Engineering teams.
- Support new product and process transfer projects; conduct reviews of risk analyses (PFMEA) for various processes.
- Plan, coordinate, and implement projects focused on preventing in-process defects.
- Develop and execute process control strategies.
- Facilitate the Quality Control supervision function through collaboration with Quality Engineers and Supervisors.
- Review and approve documentation, investigations, and other regulatory submissions within the company's quality system.
- Provide technical assistance to the In Process Quality team and other departments.
- Deliver training sessions related to quality technologies.
- Coordinate with corporate teams to implement projects related to In Process Quality.
- Create and enhance procedures for In Process Quality to ensure regulatory compliance.
- Act as Subject Matter Expert (SME) for various chapters of the company’s quality system.
- Participate as a core team member in the new product transfer process, representing Quality Assurance.
- May act as NCEP System administrator for the area, ensuring timely closure of investigations.
- Support the Quality Director in their responsibilities as needed.
- Engage in the Product Inquiry Report (PIR) process, ensuring diligent execution of related activities.
- Provide guidance and oversight to various validation areas and complaint handling processes.
Qualifications:
- Bachelor's degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field.
- A minimum of 10 years of experience in a similar role.
- Proficiency in English (desired level: 90-94%).
- Knowledge of statistical and quality techniques; ASQ certification is preferred, along with familiarity with Six Sigma, Lean, APQP, or similar methodologies.
- Or an equivalent combination of education and experience.
About Boston Scientific:
As a leader in medical science for over 40 years, we are dedicated to addressing the most significant challenges in healthcare. 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 communities. We believe in applying our values to everything we do, both as a global business and as a responsible corporate citizen.
Benefits:
- Life-Work Integration
- Community Engagement
- Career Development Opportunities
At Boston Scientific, you will discover a collaborative culture driven by a passion for innovation. With determination, creativity, and a commitment to human life, we are tackling some of the most pressing challenges in the healthcare industry. Together, we are a global team dedicated to making a positive impact on lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your work.
