Sr. Quality Systems Engineer- Global Risk Management

Boston Scientific•Marlborough, MA

51d•$86,600 - $164,500

About The Position

Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC's Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Requirements

Bachelor's degree in Science, Health, or Engineering.
Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Nice To Haves

Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

Responsibilities

Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
Supporting internal and external audits and audit responses for existing products.
Monitoring compliance with company policies and procedures.
Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.