SSi People · 4 hours ago
Senior Specialist QA
Thousand Oaks, CA
Full-time
Remote
Mid, Senior Level
2+ years exp
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Responsibilities
Collaborate on the improvement, transfer, and sustainment of QMS processes across our client’s Operations and R&D to the Digital QMS platform.
Lead Digital QMS audit & inspection readiness, deviations, and change control activities.
Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS.
Oversee documents/records within the Quality Management System.
Monitor process key performance indicators and metrics.
Manage external contractors providing services to the Digital QMS.
Qualification
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Required
Strong knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards.
Ability to converse technically with mechanical, electronic, software, and quality engineers.
Experience managing implementation of Quality Management System Requirements, Product Standards/Regulatory Requirements.
Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities.
Proficient in working on multiple projects in a deadline-driven environment.
Effective verbal and written communication skills in English.
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience.
Company
SSi People
SSi People, located in Cranberry Township, PA, is an organization with over 25 years of staffing industry experience across various labor verticals in the United States, serving Fortune 1000 companies.
51-200 employees
H1B Sponsorship
SSi People has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Ron Seibert
President and CEO
Company data provided by crunchbase
