- Implementing internal requirements and external regulations and standards relevant to quality systems.
- Demonstrate familiarity with internal requirements and external regulations, incorporating them into the necessary Boston Scientific business processes. Offer support during External Inspections as needed.
- Identify potential areas of noncompliance or opportunities for improvement through conducting Internal Audits on schedule.
- Continuously review and update Quality System procedures.
- Educate different functional areas on quality system requirements.
- Collaborate cross-functionally and across business units to standardize Boston Scientific Quality System policies and procedures.
- Collect and provide business/quality system process data from various parts of the company for analysis.
- Act as a knowledgeable resource on external regulations and standard requirements for cross-functional teams.
- Support the site's corrective and preventive actions process as a mentor. Additionally, provide expert support to prevent the unintended movement of product or components within the containment function on site. May also be required to offer support to other sites in this area of responsibility.
- Hold a Level 8 degree qualification in engineering or science.
- Have 2-3 years of quality experience in a GMP environment.
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Quality Systems Engineer I - Clonmel, Ireland - Boston Scientific
Description
Additional Locations: Ireland-Cork; Ireland-Clonmel; Ireland-Galway
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, you'll have the chance to unleash all your potential by collaborating with diverse and high-achieving teams, taking on vital challenges in the health industry. With access to cutting-edge tools, knowledge, and training, we're here to help you enhance your skills and advance your career. No matter your goals, we'll support your progress.
About this Role:
The Quality Systems Engineer will be responsible for creating and maintaining effective quality system frameworks to ensure consistent compliance at Boston Scientific Clonmel. This role involves developing processes and enhancements to uphold internal requirements and external laws, regulations, guidance, and standards (LRGS), ultimately assisting in delivering top-quality products to customers.
Responsibilities:
Qualifications:
Requisition ID: 582793
As a leader in medical science for over four decades, we are dedicated to addressing the most critical challenges with a profound concern for human life. Our mission to advance science for life revolves around transforming lives through innovative medical solutions that enhance patient well-being, provide value to our customers, and benefit our employees and the communities we serve. Now, more than ever, we have a duty to uphold these values in all our actions – both as a global business and a responsible corporate citizen.
Therefore, embarking on a career with Boston Scientific (NYSE: BSX) is more than just professional; it's personal. If you possess a natural inclination for problem-solving, along with the creativity, determination, and passion to make a significant impact on a global scale, we invite you to submit your application and anticipate the opportunity to engage with you!