About the position
At Asensus, we are digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus looking for a fulfilling career, and that's exactly what they find. The role will be part of the Design and Operations Quality team, which is part of the Global Quality team. This role will be responsible for conducting activities associated with product development processes at Asensus globally from a Quality perspective, to provide a compliant, safe and effective product that meets customer needs, focused on Software. Activities include generation and management of SOP's, generation and review of documentation, audits, participation in process improvement programs, supporting the product development teams ensuring the quality objectives are understood and achieved. The Design Quality Engineer - Software shall ensure that software systems used in development, manufacturing and as part of medical devices are established according to requirements.
Responsibilities
- Conducts SW Design quality activities supporting global product development; assists in the development of design concepts, prototypes and product specifications as part of the development team
- Provides expertise and guidance to Software design verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles
- Assists in writing and reviewing protocols, reports, work instructions, and SOPs to support product and process development
- Ensure compliance to IEC 62304
- Defines and develops SW risk management activities including creation and maintenance of risk management files
- Drives improvements to QMS as a result of quality events, audits or regulatory changes to ensure compliance with FDA 21 CFR 820, ISO 13485, and adoption of best practices
- Ensures compliance with Asensus quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles
- Contributes to develop and maintain processes and controls to ensure software safety, effectiveness and cybersecurity
- Builds and maintains a strong and fruitful relationship with SW and global R D for Design quality aspects
- Contributes to cross-functional activities that support business goals
- Support EFT management as assigned
- Supports internal audits and CAPA activities as applicable
- All Other Essential Duties as directed
Requirements
- Bachelor's degree in engineering discipline. Master's degree in engineering discipline preferred.
- 5+ years in a quality engineering role in the Medical Device field or highly regulated industry
- Minimum 3+ years in a quality role with focus on Software
- Knowledge of and experience in IEC 62304 and experience with software design and validation for medical devices
- Knowledge of the standards related to medical devices, including ISO 13485, 21 CFR Part 820 and ISO 14971
- Understanding of design control, disciplined product development processes, regulatory, and quality requirements
- ISO 13485 inspections and FDA inspections experience preferred
Nice-to-haves
- ASQ Certification as Certified Quality Engineer or Software Quality Engineer preferred
- Experience in Human Factors/Usability Engineering for Medical Devices is a plus
- Experience with CAPA's and Internal Audits is a plus
- Experience with and knowledge of specific standards is a plus: IEC 60601, IEC 80601-2-77, IEC 81001-5-1
Benefits
- A culture-driven environment to achieve our mission and deliver remarkable results
- Coworkers committed to collaboration and winning the right way
- Quality products that improve the lives of our customers and patients
- Ability to discover your strengths, follow your passion and find your own rewarding career
- Flexible, engaging work environment
- Competitive benefits package
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