196 applicants
Endpoint Clinical · 2 days ago
Senior Quality Engineer
United States
Full-time
Remote
Senior Level
$85K/yr - $105K/yr
4+ years exp
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Hiring Manager
Melissa Tran Araza, PHR
Insider Connection @Endpoint Clinical
Responsibilities
Host, support, and participate in client external audits, including coordination and preparation of audit responses, and follow-up activities.
Design, implement, and evaluate process improvement efforts cross-functionally across endpoint departments, collaborating closely with operational delivery stakeholders.
Performs and participates in audits and management of critical service providers and vendors by verifying that the vendor meets minimum regulatory, privacy and security requirements, including ensuring timely follow through on observations.
Advise, collaborate, and/or manage efforts relating to internal and external tool validation in line with documented assessments of risk and defined scope of usage.
Provide consultative support in matters of Quality Management System development and Computerized Systems Validation (CSV).
Support the CAPA program including facilitating the completion of outstanding CAPA actions with the appropriate stakeholders, participating in and orchestrating Root Cause Analysis meetings with the applicable endpoint staff, defining and implementing Corrective Actions and Preventive Actions, and evaluating the effectiveness of past CAPAs.
Perform development and revision of Controlled documents such as Policies, Standard Operating Procedures, Templates and Work Instructions, including ensuring that procedures meet minimum regulatory, privacy and security requirements.
Support all aspects of the Internal Audit program, including preparation of the audit plan, execution of the audit, and creation of Internal Audit reports upon assignment.
Work closely with internal departments, including Operations, Product Development, and Information Technology to assure compliance with internal quality systems and regulations issued by the Food and Drug Administration (FDA) and other applicable regulatory bodies and with applicable privacy and security requirements.
Participate in conducting periodic Product Quality and Management Review, including tracking, trending all KPIs (QTC metrics) and design action plans to address trends.
Represent QTC on multi-disciplinary project teams as required.
Qualification
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Required
M.S. degree and minimum 4 years of related experience OR BS/BA degree and minimum 6 years of related experience
Familiarity with the appropriate regulations, including 21 CFR Part 11, Good Clinical Practices (GCPs), Annex 11, applicable ICH guidelines (ICH E6)
Relevant experience preferably in the clinical trial industry, IRT experience is highly desired
Certification in Quality Assurance or Regulatory Affairs preferred
Experience in developing SOPs for quality assurance and compliance
Strong communication (written and verbal), organizational, and interpersonal skills
Demonstrated ability to work in a fast-paced, cross-functional team environment
Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented
Proactive team player enthusiastic with high work ethics
Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
Project management skills and high level of attention to detail
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(K)
Paid time off (PTO) or Flexible time off (FTO)
Company bonus where applicable
Company
Endpoint Clinical
Endpoint Clinical designs, engineers, and tests interactive response technology platforms that enables data access through phones.
501-1,000 employees
H1B Sponsorship
Endpoint Clinical 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
Trends of Total Sponsorships
2021 (16)
2020 (11)
Funding
Current Stage
Late StageTotal Funding
$1.7M2010-03-01Debt Financing· $1.7M
Leadership Team
C
Christine Oliver
CEO
Nicholas Mistry
Chief Technology Officer
Recent News
Company data provided by crunchbase
