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Our Mission:
At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care.
We are seeking a Senior Quality Manager (Complaint Investigations Galway) on a permanent basis to join us on our mission.
Job Purpose
Develops, establishes, and maintains quality assurance programs, policies, processes, procedures and controls. Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors. Work closely with CCC and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.
Key Responsibilities
Education & Experience
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please let us know.
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