About Company

Join Alimentiv 2 as a Remote Sr. Quality Assurance Specialist - Medical Device

Date Posted: July 15, 2024

Company: Alimentiv 2

Location: USA (Remote)

Job Overview

Alimentiv 2 is seeking a remote Senior Quality Assurance Specialist - Medical Device. This role is a senior technical position focusing on Quality Assurance for medical devices. The ideal candidate will possess advanced technical knowledge in clinical trial operations, regulations, industry standards, and an understanding of research ethics and privacy.

Key Responsibilities

Quality Planning, Execution, and Oversight

• Develop and implement QA plans, including study, internal process, and annual plans.
• Manage department projects to ensure high-quality deliverables that meet timeline commitments.
• Monitor and evaluate quality indicators, QA reports, and audit responses.
• Support study operational teams with resolution of escalated issues.
• Identify quality risks and design mitigation strategies.
• Lead investigations, audits, and QA-related corporate initiatives while mentoring QA staff.

Regulatory, Ethics, and Privacy Support

• Act as a senior representative of Quality at meetings.
• Support Sponsors and operational teams with global quality, regulation, ethics, and privacy inquiries.
• Stay updated on industry environment and global regulatory legislation.
• Mentor QA staff in developing standard operating procedures.

Technical Expertise, Mentorship, and Training

• Serve as a technical role model and mentor to the quality team.
• Assist the Director with departmental budget activities concerning audits and associated costs.
• Develop and provide training both within and outside the department.

Qualifications

• Bachelor's degree with 7-9 years of related experience.
• Fluent in English (additional languages are a plus).
• Ability to operate independently with minimal support.

Additional Knowledge/Skills

• Certification in GCP, ISO 13485, or MDSAP auditing.
• Knowledge of medical imaging, AI/machine learning, and software as a medical device (SaMD).
• Strong written, verbal communication, and presentation skills.
• Proven critical thinking and analytical skills.
• Strong change management and interpersonal skills.
• Experience in cross-functional global team environments.
• Ability to work independently and self-motivate.

Working Conditions

• Remote, home-based position.
• Accommodations available for job applicants with disabilities.

If you meet the above qualifications and are ready to take your career to the next level, we encourage you to apply for the Sr. Quality Assurance Specialist - Medical Device position at Alimentiv 2.