Boston Scientific Quality Engineer Design - P3 

Ireland 

676367906

Develops, establishes and maintains design quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused design quality engineering support within new product development, operational and/or system/services support.

Responsibilities:

• Responsible for supporting PD, Manufacturing and R&D projects for multiple Boston Scientific Divisions. Projects include both implantable, external, capital systems and SUD’s.
• Creation and review of risk management documentation throughout the product lifecycle.
• Creation and review of Validation lifecycle documentation throughout the product lifecycle.
• Creation and review of risk management tools such as FTA’s, FMEA and FMECA.
• Creation and review of software, mechanical and hardware DQA documentation as required
• Support all aspects of DQA activities during audits, as needed
• Responsible for complaints processing through NCEP and CAPA as needed
• Performs other duties as directed

Requirements:

• 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.
• Applies sound risk management principles compliant to ISO60601 and ISO14971.
• Demonstrate a primary commitment to patient safety and product quality.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving design quality issues.
• Acts as a team member in supporting quality disciplines, decisions, and practices.
• Ideally has experience with IEC 62304, IEC62366, 93/68/EEC, ISO10993 and ISO 14155, MDD/MDR.
• Provide quality system oversight of Neuromodulation NPD and sustaining programs on site
• Demonstrate excellent report writing skills, attention to detail and strong reviewing ability.
• Keen ability to perform unbiased assessments of software, mechanical and hardware systems.
• Effectively communicate and collaborate within the department and across the organization by proactively driving solutions and escalating as needed.
• Work closely with other departments as required to ensure quality driven approach.
• Acts as a leader of quality, QSR and ISO/MDD/MDR standards within one’s own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.

Qualification:

• Level 8 engineering, software or science related discipline with 3 to 5 years relevant work experience
• Proven experience within a quality role encompassing mechanical, electrical and PCB assembly would be advantageous