Senior Quality Engineer - Software Auditor and Cybersecurity
Location
Marlborough, MA | United States
Job description
Additional Location(s): US-MN-Maple Grove
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.
About the role: Due to the increasing complexity of clinical trials and regulatory obligations, the components of a Clinical Quality audit program are constantly evolving, especially in the software validation and cybersecurity related areas. This Sr. Quality Systems Engineer global role will work directly with the Clinical Quality Auditor lead and serve as the software quality representative that performs, supports, and maintains clinical vendor software assessments for all of Boston Scientific’s external clinical vendors. The software assessments will review the vendor’s compliance to various regulations, their software development lifecycle (SDLC) and related software validation procedures. In this role, you’ll learn about cybersecurity controls and work with the team to build these controls into the quality system. Two parts of the role will include clinical software auditing and building cybersecurity controls within the Quality System.
Your responsibilities will include:
- Play a key role in vendor management by identifying the software quality system needs from a vendor and ensures that vendors are qualified in a manner including performing SDLC Assessments for software vendors including clinical.
- Partner with the audit team and support decision making if a software assessment is needed for clinical and medical device vendors.
- Perform Quality Software Vendor assessment audits to review compliance to FDA Part 820, IEC 62304, ISO 13485, ISO 14971, MDR, and MDSAP requirements.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
- Develop and contribute to audit reports including scope, audit details, clearly communicate findings with identified risk severity, likelihood, impact, and risk remediation recommendations.
- Following up on activities to address outcome of conducted audits until their resolution.
- To own the software auditing processes, which are always evolving.
- To fulfill all duties and responsibilities in line with the established timelines.
- Providing support in definition of requirements for quality improvement initiatives
- Active participation in quality improvement projects as defined by management/leadership
- Assists in supporting and enhancing the operational processes for Quality System Post Market and Premarket cybersecurity
- Supports development and maintenance of Quality Systems processes (work instruction, knowledge sharing documents, standard operating procedures) needed for pre and post market product cybersecurity.
- Provide Quality support for Global Product Cybersecurity engineering including collaboration with BU R&D, IT and other BSC functions.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Required Qualifications:
- Bachelor’s level degree in Science/Engineering/Computer Science/Software Engineering discipline
- Minimum of 2 years of related experience, including experience supporting Quality Systems for Software or related discipline
- Minimum of 5 years of technical experience in a regulated industry
- Minimum of 2 years of experience with internal auditing and corrective and preventive action (CAPA)
- Working knowledge of regional and international quality system requirements including 21 CFR 820 (including Part 11), ISO 13485, EU MDR, cGxP for Medical Devices, Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance and 81001-5-1
Preferred Qualifications:
- Must have good understanding of quality system requirements and how each quality system element connects.
- Knowledge of Software Development Life Cycle (SDLC) & Agile techniques
- Ability to work independently and collaborate with cross-functional teams to complete projects
- Strong critical thinking and analytical skills: process and results-oriented
- Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively
- Clinical experience or knowledge of clinical evaluations beneficial
- Qualifications of an auditor
- Knowledge of Clinical Trials regulations (both US and rest of the world) including ISO 14155 and 21 CFR 812
- Basic Understanding of HIPAA/GDPR and data security regulations beneficial
- Experience/Understanding of risk management as per ISO 14971
- Experience with CAPA, Vendor Controls, Complaint Handling and External Audits
- Experience working with a diverse population of internal and external customers
- Previous Quality Medical Device or Pharma experience
- Conducted Vendor Audits in the past
- Skilled at testing process and methodologies
- Software development experience
- ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)
Job tags
Salary
