Senior Design Assurance Engineer

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Purpose

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.  Support the application of Design Controls in Product Development and Sustaining Changes ensuring that all changes are compliant to associated Pharmaceutical Regulations and Methods. 

Responsibilities

• Familiarity with requirements and procedures that govern the Pharmaceutical Industry including Eudralex Volume 4, GMP Guidelines", FDA 21 CFR 210, 211; GxP plus ICH Q8, 9 & 10.
• Manage and resolve product issues related to manufacturing, quality, or field performance.
• Support change control and risk management processes and generate documentation in alignment with quality system requirements
• Development and lead the execution of stability plan, protocols and reports for drug products through the life cycle of the product
• Coordinate and contribute with analytical test laboratories and teams for product investigations, OOS, OOT and significant change events
• Provides Quality support in the resolution of complaints investigation, CAPAs, NCMRs, Deviations, Root Cause Analysis and regulatory requirement changes.
• Summarise clear, concise conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities
• Uses knowledge of Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Acts as SME in notified body audits and regulatory compliance for areas of expertise.
• Work with supply chain, incoming materials and packaging/labelling to ensure product is supplied to stringent quality levels.
• Interfaces with R&D, Regulatory Affairs, Operations, Validations, Clinical, Medical Safety and Pharmacovigilance providing technical input.

Can work independently and is fully motivated to achieve and demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality

• Coaches and gives technical guidance to Design Assurance Engineer team members to support the business growth strategy.

Qualifications and Experience:

• NFQ Level 8 qualification in a STEM discipline
• Familiar with Minitab and data Analysis
• Minimum of 5+ years’ experience in the Pharmaceutical Industry
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
• Experience leading/supporting multiple complex projects and assignments.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

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 email TalentAcquisitionIre@bsci.com.