JOB OVERVIEW

About the Role - >
We are seeking a highly motivated Quality Systems and Product Compliance Specialist to support our Quality Management System (QMS) and ensure compliance with applicable regulations, standards, and company policies. This role will be responsible for maintaining quality processes, supporting audits, managing product compliance documentation, and driving continuous improvement initiatives across the organization.

QUALIFICATIONS

Bachelor’s degree in Life Sciences, Engineering, Quality Management, or related field (Master’s degree a plus).

• 3–6 years of experience in quality systems, compliance, or regulatory affairs in a regulated industry (medical devices, pharmaceuticals, biotech).
• Strong knowledge of QMS standards (ISO 9001, ISO 13485, FDA 21).
• Experience with compliance software tools (e.g., SmartSolve, TrackWise, Veeva, or similar QMS platforms).
• Excellent communication, documentation, and organizational skills.
• Analytical mindset with the ability to manage multiple projects and deadlines.

PREFERRED SKILLS

• Certification in Quality/Regulatory (e.g., ASQ CQA, CQE, RAC, Six Sigma) desirable.
• Experience preparing RFPs, compliance reports, or regulatory submissions.
• Familiarity with product safety standards and global compliance frameworks.
• Strong presentation skills with the ability to communicate with stakeholders at all levels.
  Job Type: Contract
  Work Location: Remot

• Support the development, implementation, and continuous improvement of QMS processes and architectures.
• Work with systems such as IQVIA/Smartsolve to maintain compliance and streamline workflows.
• Develop high-quality documentation including process diagrams, scorecards, RFP documents, and presentations.
• Partner with cross-functional teams to ensure clear communication and alignment on quality initiatives.
• Provide analytical support and contribute to QMS reporting and metrics tracking.
• Collaborate with leadership to ensure effective execution of quality strategies.
• Product Compliance
• Ensure product compliance with applicable global regulations (FDA, EU MDR etc.).
• Prepare and maintain product compliance documentation, technical files, and declarations of conformity.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure design and process controls meet compliance requirements.
• Support supplier qualification and audits to ensure material/component compliance.
• Bridge the gap between receiving business requests and translating them into system user requirements.
• Collaborate effectively with delivery teams (both third-party vendors and in-house resources) to assess feasibility and ensure alignment.
• Support the development and optimization of Product Complaint systems in particular.
• Building and optimizing Product Complaint systems.
• Serving as a business liaison to technical delivery teams.
• Translating business processes into clear, actionable system user requirements.
• Additionally, the technical aspects of process nomenclature, automation, and system design, which are essential to ensuring successful business-to-system translation.
• Given our current business needs, the assessment and liaison function is where we require the most support.
  We have a high volume of requests for technical improvements, and the right candidate must be able to: