Job Detail

Purpose

The Manager Quality Systems plays a key leadership role in driving the Boston Scientific Quality Culture. He/she will continuously foster and drive a continuous improvement approach to Quality ensuring that quality is the responsibility of everyone - not just the QA department and that the Quality System is an integrated and integral aspect of monitoring performance.

Responsibilities

• Responsibility for ensure compliance of the Global Quality System to all applicable regulatory requirements and other international requirements as applicable


• Responsibility for the Quality System Management Controls Process, including the coordination of Management Review and Quality Planning


• Responsibility for the establishment of implementation plans for External Regulation changes which impact the Boston Scientific Quality System


• Responsibility for Management of Notified Body relationship


• Oversight of Doc & Records Control (Windchill, etc.)


• Oversight of Global Regulatory Compliance (GRC) Internal Auditing Team


• Responsibility for External Corporate Audit Support (incl. responses)


• Acquisition Integration Strategy Alignment


• Responsibility for the CAPA and PIR process


• Support Regional Quality System plans

Your profile (Experience, Skills, Education):

• Bachelor’s degree in a technical field


• 10 years’ experience in the medical device industry


• Experience in leading organizations through FDA, Notified Body and other International Reg Agency Audits


• Strong knowledge of appropriate state, Federal and international regulations impacting the company


• Attention to detail and accuracy and Problem-Solving Skills


• Good business acumen


• Ability to work well under deadlines and pressure


• Ability to communicate clearly, accurately and directly – both verbally and in writing – to a widely varied audience in English and ideally French

In addition to an exciting job we offer you an attractive compensation package, very good options for a personal and professional development through an established talent management program in our organization. Above all, you will have the opportunity to become part of a corporate culture where everyone contributes to improving people's lives. Please let us know more about you by applying in English and clicking on the link below.

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