Project Quality 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.

The Quality Engineer serves as a Quality team member in a strategic project Core Team to support implementation and to increase awareness, visibility and communication on quality aspects of the project. The Quality Engineer demonstrates in all actions a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

• Actively participates as a quality core team member in a strategic site project.
• Pro-actively implements Quality standards, principles and procedures in the operational processes to ensure that processes are executed per Corporate and Regulatory requirements.
• Understanding of process validation life cycle, incl. process characterization, IQ, OQ and PQ.
• Support Process Validation activities as required per the project requirements, incl. support in developing, reviewing and release of validation documentation such as validation plans, protocols and reports.
• Participate in process risk analysis.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues (CAPA, Is/Is not problem statement, Fishbone diagram, Pareto, FMEA).
• Effective cross functional communication with operations, logistics, engineering, and quality assurance teams.
• Understands and applies quality principles to support an effective overall quality management system.
• Supports change control activities.
• Supports in the development and review of process related documentation (SOPs, Work Instructions).
• Flexibility to perform general QA related activities.
• Prioritization of patient impact during decision making, risk assessments, and change control.
• Drives awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific.

• 3+ years experience ina GMP/GDP environment with Bachelor’s Degree or equivalent. Prior experience in the medical device industry is preferred.
• Comprehensive understanding of the EU MDR, ISO 13485 and ISO 14971 standards
• Experience in process validation is required
• Proficiency in statistical analysis, sampling strategies, and process capability assessments.
• Competency in risk management tools such as pFMEA and Process Hazard Analysis.
• Demonstrates knowledge in teamwork, project management, problem solving and risk management techniques
• High level of organizational skills and ability to manage multiple validation activities simultaneously
• Good social and communication skills
• Strong documentation skills to ensure traceability and compliance.
• Good knowledge ofthe English language (verbal and written)

• Experience with supply chain distribution and packaging
• Medical device industry experience

• Fixed term contract – 1 year
• Attractive benefits package - very competitive salary (including 8% holiday pay, 13th month and yearly bonus)
• 30 days of annual leave
• A very good pension scheme
• Excellent training/development programmes to influence your career
• Inhouse gym facility (free of charge)
• Inspirational colleagues & culture
• Fast Growing and innovative environment
• A team-oriented company culture
• International opportunities

Does this position sound like the next step in your career? We look forward to receiving your application! Join a team that works together to find solutions that make a difference!

Requisition :620754

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most –…