Quality Engineer - P1

Additional Locations:  N/A

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.

Purpose Statement

Fulfil the quality assurance responsibilities of BSC’s new product development, sustaining and post-market (commercial product) support, including:

• Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in BSC.
• Understanding and complying to BSC’s quality, business, health & safety systems and market/legal regulations governing the quality systems.
• Removing or mitigating against risks associated with the design, use and manufacture of BSC devices.
• Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.

Key Responsibilities

General

• Completes work assignments under limited supervision/guidance.
• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
• Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
• Seeks to support improvements in product and process quality.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Excellent interpersonal and communication skills with good leadership abilities.

Technical

• Provides both quality and technical input to ongoing product development, product sustaining and post-market commercial product activities.
• Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements). 
• Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes.
• Analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.

Education 

• Minimum of Bachelor of Science Degree Level 8 in Engineering/Technology.
• 1/2 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
• Experience in the medical device industry is an advantage.

Requisition ID: 615509

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 (NYSE: BSX) 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!