Senior/Principal Quality Engineer - Software Auditor
- Remote Eligible: Hybrid
- Onsite Location(s): Marlborough, MA; Arden Hills, MN; Maple Grove, MN
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 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.
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
Required qualifications:
- Bachelor's level degree in Science/Engineering/Computer Science/Software Engineering or related discipline
- 2+ years of related experience, including experience supporting Quality Systems for Software or related discipline
- 5+ years of technical experience in the medical device or pharmaceutical industry
- 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 and cGxP for Medical Devices
- Knowledge of Software Development Life Cycle (SDLC)
- Ability to travel up to 10% (domestic or international)
Preferred qualifications:
- Knowledge of Clinical Trials regulations (both US and rest of the world) including ISO 14155 and 21 CFR 812
- Experience/Understanding of risk management as per ISO 14971
