Sr Manager, Quality Engineering

MML US Inc•San Diego, CA

2d•$180,000 - $200,000

About The Position

The Senior Manager, Quality Engineering will operate as a strategic leader and an execution-focused contributor leading Quality Engineering and supporting the Quality Assurance teams at Mainstay Medical, with expertise in Software as a Medical Device (SaMD), embedded software, and traditional medical device hardware (Class I through III). This individual will be responsible for ensuring that the total product lifecycle (TPLC) process and products are compliant with applicable standards, regulations and guidance documents, and continuously improving the design control and post market process to the evolving regulatory environment in multiple jurisdictions, with a focus on scalability for software products including cybersecurity and software risk management. This individual will partner closely with cross-functional team members in Product Development, Regulatory Affairs, Clinical, Operations, and IT.

Requirements

B.S. degree in engineering/scientific/computer systems, or related field.
A minimum of 8+ years work experience in Quality Engineering within an FDA, ISO or other regulated environment and a minimum of 3 years of people management experience.
A minimum of 5+ years experience with medical device software development, including software mobile medical applications (MMAs), firmware, cloud-based systems, and cybersecurity.
Experience in the development and implementation of effective Design Control Systems, including working knowledge of QMSR (revised FDA 21 CFR Part 820) and ISO 13485 quality system standards, and SDLC per IEC 62304.
Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and premarket regulatory submission requirements.
Strong knowledge of risk management and usability engineering standards (ISO 14971, IEC 62366).
Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
Excellent communication, technical writing, and cross-team collaboration skills.

Nice To Haves

ASQ, CSQE or other software quality certificates are beneficial.
Working knowledge of data privacy requirements in U.S. and EU (GDPR) desired.
Experience coordinating or leading audits beneficial.

Responsibilities

Lead, coach, and develop a team of quality professionals and establish a culture of quality amongst the team and collaborative nature while partnering with stakeholders across the organization.
Ensure product development and product sustaining activities comply with regulatory standards including FDA revised 21 CFR Part 820 (QMSR), EU MDR 2017/745, ISO 13485, IEC 62304/82304, ISO 14971, and IEC 62366, and other applicable guidance related to all Mainstay Medical products, including active implantable medical devices and software as a Medical Device (SaMD).
Maintain and continuously improve a scalable QMS to comply with regulatory requirements (U.S. FDA, EU MDR, TGA) and industry best practices, including creation and maintenance of Software Development Lifecycle (SDLC) procedures and work instructions.
Support and contribute to execution of risk management activities in compliance with ISO14971 and software risk requirements in IEC 62304.
Support efforts for cybersecurity and security risk management for both U.S. and global requirements, as applicable where product is commercialized.
Manage trend monitoring and CAPA system, including root cause analysis and effectiveness checks.
Lead Design Control and Software Development Quality projects and initiatives to ensure Design History File documents for Class III medical devices, mobile medical applications (MMAs), cloud-based systems, and cybersecurity controls meet regulatory expectations for premarket submissions and audits. This includes providing timely guidance and expertise during creation and review of software development artifacts such as software requirements, architecture, design documentation, risk management, planning documentation, V&V protocols/reports, and release notes; and evaluating design updates and impact assessments for software updates.
Provide guidance on and participate in development activities including design reviews, risk reviews, requirements analysis and tracing, defect tracking and investigation, and configuration management.
Responsible for supporting supplier quality management, ongoing performance monitoring, receiving inspections, NCMRs, and supplier audits.
Establish and maintain supplier quality frameworks for software vendors, cloud providers, and contract manufacturers.
Leading efforts and team for both internal and external audits, including FDA inspections and notified body audits.