- Act as an effective leader in supporting quality disciplines, decisions, and practices.
- Define and lead strategy advancement of technical insight and product performance improvement.
- Defining best approaches and statistical techniques to product performance during launch, sustainment, and EOL
- Develop and maintain Post Market Compliance programs, policies, and processes.
- Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Drive projects of major magnitude and scope with value saving & compliance related opportunities.
- Recruit, coach, develop, and lead organizational talent.
- Manage product investigation workloads and processes to ensure timely investigation and escalations as required
- Provide oversight to work done offsite and by 3rd party vendors.
- Determine appropriate staff levels, schedules, and resources.
- Work cross-functionally and across sites to identify and resolve issues.
- Level 8, 240 credits, in Science or Engineering (Level 9 desirable)
- Leadership in problem-solving, process improvement across engineering, and cross-functional teams
- In depth knowledge of Quality Systems, Medical Device manufacturing and regulatory requirements over a minimum of 9 years.
- Experience achieving product improvement across organisation e.g. Post Market, DA, operations, supply chain, supplier, and field-based organizations.
- Strategic experience in technical failure analysis and/or data analytics
- Excel in Collaborative Leadership with the ability to influence.
- Experience in managing large-scale, complex operations/programs/projects with results.
- Experience with BSC Quality systems and methods, products, customer needs & lean business/VIP experience.
- Financial experience in cost centre planning and execution responsibility.
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Senior Quality Manager - Galway, Ireland - Boston Scientific
Description
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 , 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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