Software Quality Manager – Milpitas, US
Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT
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Corin is seeking a Software Quality Manager to provide support and oversight for the system and software development performed Corins Milpitas site. Ensuring that all development activities are compliant to FDA, ISO and European Medical Device quality standards and regulation, with a focus on the on-going improvement of software and quality system processes.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip & knee solutions and world leading technologies, our OMNIBotics & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
The responsibilities of the Software Quality Manager are to;
* Work within cross-functional teams and actively participate in the product development cycle. Work closely with the Software and Product Development teams to define requirements, develop appropriate verification and validation tests, participate in system and component risk assessments and design reviews.
* Provide software quality guidance and support throughout the product and software development life-cycle.
* Support the application, compliance, and continuous improvement of policies, procedures, and documents related to software development and validation including risk management, software and system validation, quality investigations, and traceability.
* Review and perform gap analysis on Software Development Lifecycle procedures in order to establish an overall framework for compliance to IEC 62304 and computer system validation. Develop the controls and procedures required to support a compliant Software Development Lifecycle process.
* Promote awareness of applicable standards, regulatory requirements and quality management system requirements throughout the organisation.
* Provide QA oversight to assigned software suppliers and service providers. Interface as necessary with suppliers to ensure product specifications are met. Lead supplier audits and assessments for software supplier and software service providers.
* Support and lead Corrective and Preventive Actions and complaints to ensure documentation and findings are completed in a timely manner in accordance with regulations, standards and procedures.
* Perform internal audits on Quality System processes to ensure procedural compliance to relevant standards and compliance by the organization to documented procedures.
* Active involvement in external audits, including preparation, participation and responding to audit findings as it relates to Software development.
* Identify improvements in Quality System Practices and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
The ideal Software Quality Manager will have / be;
* A bachelors degree in Life Sciences, Medical or Engineering, combined with a minimum of 5 – 8 years experience within Quality Assurance, Medical Devices and Software Development.
* Deep understanding of ISO 13485 and IEC62304 standards and their application
* Experience with product and software development
* Able to manage multiple projects and to determine project urgency
* Able to manage fast timelines and competing deadlines
* Abile to work independently as well as in team
* Self-directed and results orientated
* An exceptional communication, interpersonal and relationship management skills
* Customer and quality focused
* Creative with the ability to think outside the square, showing a high level of initiative
* A positive attitude to change and a passion for innovation
Corin US is an equal opportunity employer. Qualified applicants are considered without regard to age, gender, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity, disability, veteran status.