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Resonant Clinical

End-to-end clinical trial logistics & services

Quality Manager - Kitting

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeStříbrná Skalice, CzechiaNo salary listed

About the Job

Requirements

  • A bachelor's degree is required.
  • At least 6 to 8 years of progressive experience in a regulated industry, such as medical devices, IVD diagnostics, pharmaceuticals, or a similar field.
  • At least 3 years of people leadership or management experience.
  • Demonstrated experience with regulatory inspections, certification-body audits, and/or customer audits.
  • Strong knowledge of ISO 13485, 21 CFR § 820 (QSMR), and the European Medical Device Regulation (EU MDR).
  • Demonstrated ability to assess and continuously improve quality management systems.
  • Experience systematically managing incoming, in-process, and final inspections.
  • Practical knowledge of Six Sigma and Lean Manufacturing principles applied to quality systems.
  • Ability to lead, coach, and influence employees and cross-functional partners.
  • Excellent spoken and written communication skills, including communication across organizational levels and with senior leadership.
  • Ability to prioritize and manage time effectively while handling multiple deadlines.

Responsibilities

  • Ensure site-level compliance with 21 CFR § 820 (QSR/QSMR), ISO 9001, ISO 13485, and applicable EU medical device regulations and directives.
  • Oversee implementation, integration, and ongoing maintenance of the quality management system (QMS), including implementation and administration of QMS software.
  • Manage quality subsystems, including document control, training, complaints, corrective and preventive action (CAPA), nonconformances, supplier management, and internal audits.
  • Provide subject-matter support for creating, reviewing, and implementing procedures, work instructions, forms, and other process documentation.
  • Plan and lead customer, regulatory-authority, and notified-body inspections and audits, including preparation, documentation, follow-up actions, and closure.
  • Plan and conduct internal QMS audits in accordance with ISO and QSR requirements.
  • Oversee supplier evaluation and auditing, and advise procurement or supply chain management when supplier quality issues arise.
  • Serve as the quality subject-matter expert and provide support to internal teams and external customers.
  • Manage the CAPA program and collaborate with the lead auditor to ensure CAPA and internal and external audit programs are effective.
  • Lead complaint investigations, including weekly review meetings and final review before closure.
  • Oversee nonconformance management, including market corrective actions when needed.
  • Implement effective root-cause analysis practices across the organization.
  • Assess current and upcoming regulations and standards, and advise senior leadership about their impact and necessary changes across the organization.
  • Identify, support, and lead continuous-improvement projects informed by trend analysis, management reviews, complaint investigations, and audit findings, using Six Sigma and Lean Manufacturing methodologies to improve the quality system.
  • Create, implement, and maintain process improvements, key initiatives, and assigned projects.
  • Manage preparation and facilitation of management reviews, and recommend data and metrics for senior leadership to track strategic objectives.
  • Support validation programs and consult with commercial and product teams on the quality feasibility of new products; monitor product manufacturing processes and verify finished products meet specifications.
  • Collaborate with other departments to align business and process activities with regulatory requirements and site quality needs.
  • Ensure appropriate staffing and work allocation based on site and department needs.
  • Coach, develop, and evaluate direct reports and quality team members throughout the year.
  • Arrange and coordinate training on quality concepts, tools, and system requirements as needed.
  • Represent the site leader during their absence as needed.
  • Perform other assigned duties.

Desired Qualifications

  • A master's degree in quality assurance, engineering, chemistry, or another technical field is a significant advantage.

About the Company

Resonant Clinical

End-to-end clinical trial logistics & services

Resonant Clinical Solutions provides outsourced clinical trial and diagnostic logistics for pharma, biotech, CROs, and diagnostic laboratories, combining three service lines: Kitting by Therapak, Equipment & Ancillaries by MESM, and Biorepository by EPL Archives. Their three lines operate as an end-to-end platform: kit assembly, device sourcing and management, and secure sample storage and archiving, with cryogenic storage added via Creapharm Bioservices. They differentiate by uniting three established brands into one integrated partner with global reach and a track record with top biopharma clients and thousands of trials. Their goal is to handle complex life-science logistics end-to-end so customers can focus on research and patient outcomes, while Resonant grows as a standalone business.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
Claremont, CA
Founded
Not listed

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