Boston Scientific Software Quality Engineer 

Netherlands, Limburg 

618116569

About the role:
Functions as the Quality workstream lead for Equipment Software Qualification and Validation supporting implementation of an Automated Storage and Retrieval System and other systems for a project at the Kerkrade Distribution Center.

Fixed term: 1 year with potential extension upon project’s need

Responsibilities include:

• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS, Software Qualification documentation and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment, systems and processes.
• Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
• Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What are we looking for:

• 5+ years’ experience with Bachelor’s Degree or equivalent in a quality controlled environment
• Comprehensive understanding of the MDD/EU MDR, ISO standards and cGMP
• General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function.
• Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Demonstrates knowledge in teamwork, project management, problem solving and risk management techniques
• Effective team member, fully motivated to achieve and demonstrate best practices in line with the department & global objectives
• Good social and communication skills
• Strong analytical skills, eager to improve and results oriented
• Professional proficiency in English language (verbal and written)

Preferred Qualifications:

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