Quality Manager

Key Responsibilities

• Develops and manages a high-performance quality engineering team with a focus on customer needs, compliance, product quality, and risk mitigation.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
• Participates in Customer Complaints investigation for areas under their control.
• Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Site QA Director as the final arbitrator on critical quality decisions.
• Develops, directs and executes plans for major segments of complex projects from a quality perspective.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on-site and across the Corporation where possible.
• Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
• Is an effective people manager resulting in a motivated high performance team.  Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and quality objectives.
• Assists in and/or completes the development of budgets and monitors spending.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Is familiar with the internal auditing process.
• To establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area

 
Requirements

• Minimum Bachelor of Science in Biomedical Science or equivalent degree or Engineering Degree.
• Minimum 10 years of experience working in managerial capacity within a production environment in medical industry.
• Well versed in ISO 13485 and 21 CFR 820 requirements.  
• Minimum 3 years of experience managing engineers and technicians.
• Required skills: People management skills, Problem solving skills, Risk Management skills, Excursion handling skills.
• Knowledge of statistics and understanding of Finance 101 will be added advantage.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.