Boston Scientific Quality Director - Urology 

United States, Massachusetts, Marlborough 

128617808

Your key responsibilities will include:

• Ensure product safety, reliability and high quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product life cycle.
• Ensure efficient compliance to all applicable regulations through the implementation of a robust company quality system and through communication/reporting to regulatory authorities.
• Lead a team of employees in executing the organization’s mission, core values, and behaviors as well as achieving organizational goals. Recruit, coach, develop and motivate a high performing team.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.
• Keep the organization's vision and values at the forefront of decision making and action, including directing and controlling the activities and budget.
• Lead the Quality team on development projects of major magnitude and scope. Key quality voice of influence on new product development projects.
• Own and drive commercial product monitoring and all related product sustainment activities.
• Assure continuous improvement in product performance by incorporating learnings into new product development.
• Employ lean methodologies to improve the efficiency of the Quality System.
• Create an entrepreneurial environment and demonstrates effective change leadership.
• Directly interface with regulatory authorities, including internal and external audits.

What we're looking for in you:
Required Qualifications

• Minimum of a Bachelor's degree
• Minimum of 9 years of Quality engineering experience in a medical device or regulated environment or similar related work experience
• Minimum of 5 years of direct or indirect management experience
• Demonstrated ability to lead effectively across a broad and diverse body of work/functions/sites.
• Experience as a strong inclusive leader with proven experience collaborating with peers and network.

Preferred Qualifications:

• Advanced degree preferred
• Familiarity and experience with BSC design control systems and methods
• Familiarity with BSC products and customer needs
• Lean business/VIP experience
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.