Boston Scientific Quality Director Peripheral Interventions Acquisitions 

United States, Minnesota 

334297015

The Quality Director will work to ensure that systems, processes, and staffing are in place to maintain effective quality system(s) during the integration process. The Quality Director will ensure product safety, reliability, and quality through the effective use of quality planning, risk analysis, statistical methods, and process controls across the design, manufacturing, and post market stages of the product lifecycle. In this role, they will foster and enable effective and flexible integration plans, methods, and approaches that are developed and implemented to enable successful integration into the BSC Quality System, including efficient and effective compliance throughout the integration and appropriate reporting and communication with regulatory agencies. Necessary process or product remediation will be considered a critical part of the integration process. Effectively engage, partner, and influence both corporate and divisional entities to assure that BSC’s broader aims are met.The Quality Director, PI Acquisitions will be primarily located in MN, but will involve travel to active integrations sites.Your responsibilities include:

• Ensure product safety, reliability and high quality through the effective use of quality planning, risk analysis, statistical methods in the integration lifecycle.
• Ensure efficient compliance to all applicable regulations through the implementation of a robust company quality system and through communication/reporting to regulatory authorities.
• Provide overall leadership to the team in the achievement of organizational goals. Recruit, guide, coach, and develop direct reports and drive those practices throughout their organization.
• Assure continuous improvement in product performance by incorporating learnings into new product development.
• Employ lean methodologies to improve the efficiency of the Quality System.
• Develop and execute organizational and operational policies and processes that positively impact groups by utilizing technical/professional knowledge and skills.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Keeps the organization's vision and values at the forefront of decision making and action, including directing and controlling the activities and budget.
• Builds strategic partnerships to further departmental and organizational objectives.
• Engaging with cross functional partners and acquired teams/team members to enable collaborative solutions that result in broad wins.
• Providing direction and guidance to team members so they achieve individual, project, and team goals.
• Keeping the organization's vision and values at the forefront of decision making and action.
• Demonstrating effective change leadership.
• Building strategic partnerships to further departmental and organizational objectives.
• Making decisions regarding work processes or operational plans and schedules to achieve objectives.

What we’re looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 10 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 set of cross functional partners/teams and diverse body of work/functions/sites in a highly matrixed environment
• 20% travel expectations

Preferred Qualifications:

• Advanced degree preferred
• Familiarity with BSC products and customer needs
• Complex problem solving
• Demonstrated ability to influence and drive consensus across multiple parties in a highly matrixed organization
• Ability to be innovative and drive new perspectives based on industry standards and best practices
• High sense of urgency and commitment to execution
• Proven adaptability, comfortable with change and demonstrated ability to react and respond to a fast changing environment

Maximum Salary: $ 286000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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