Senior Quality Systems Manager Jobs Vacancy in Curacloud Corporation Seattle
Curacloud Corporation Seattle urgently required following position for Senior Quality Systems Manager. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Senior Quality Systems Manager Jobs Vacancy in Curacloud Corporation Seattle Jobs Details:
CuraCloud is a successful healthcare AI company with an R&D center in Seattle. We are developing AI-enabled diagnostic services for health systems and researchers, with a focus on medical image analysis and medical genomics. We are working with healthcare delivery organizations, university-based researchers, and IT services providers around the world to make a positive impact on healthcare.
Job Title: Senior Quality Systems Manager
Job Location : Seattle
CuraCloud is seeking a Senior Quality Systems Manager to implement a Quality Management System (QMS) that meets FDA and ISO requirements and that is conducive to contemporary software approaches with iterative design and development techniques. This new role is central to creating an embedded Culture of Quality and Organizational Excellence (CQOE), in which our QMS truly supports product excellence rather than mere compliance, and promotes high quality standards and innovation.
- Lead adoption of QMS Design Controls within an international Software as a Medical Device company
- Write, maintain, and administer quality systems standard operating procedures (SOPs) that can be used effectively and meet FDA and ISO quality system requirements
- Specify automated tools needed for QMS processes with an emphasis on Design Controls for software as a medical device
- Establish and maintain procedures for change control, including engineering change control process, label change control process, and process change control procedures.
- Develop and deliver appropriate training in QMS processes and maintain electronic training records.
- Work with R&D and Marketing to incorporate the QMS into routine practices
- Monitor project activity to ensure required QMS documentation is created in a timely manner
- Collaboratively create and maintain Key Performance Indicators (KPIs) to track CQOE progress
- Support QMS audits or investigations
- Maintain awareness of relevant changes in the regulatory landscape and serve as an internal consultant on regulatory issues
Mandatory Qualifications (must meet all of these)
- BA/BS degree
- Familiarity with FDA Quality Systems Regulation (eg., 21CFR 820) and/or ISO 13485 or 9001 especially as it pertains to Design Controls
- 2 years recent experience in a quality assurance or regulatory compliance role in a healthcare software or biotech organization
- Excellent interpersonal skills, presentation skills, and verbal / written communication skills
- English fluency, spoken and written
- Ability to work effectively and collaboratively in a multi-cultural setting
- Advanced experience with Microsoft Word, Powerpoint, Excel
Desirable Qualifications (must meet some of these)
- English and Mandarin professional fluency
- Experience implementing ISO 13485 and achieving CE Marks for medical devices
- Experience designing and implementing a QMS from scratch in a software organization
- Advanced degree in business or STEM
- Regulatory affairs degree or certificate
- Experience developing software as medical device and getting FDA clearance or approvals
- Laboratory Developed Test (LDT) experience
- QMS auditing experience
- Demonstrated leadership experience
CuraCloud Corporation is an equal opportunity employer and all qualified applicants will receive consideration for employment. We will provide competitive salaries and benefits.
Job Type: Full-time
- quality assurance: 1 year