Open Position: QA Manager

Function: Quality Assurance 

Summary

EdgeOne Medical is seeking a QA Manager to join our growing organization. The role will report directly to the Senior Director of Quality in a rapidly growing organization providing Medical Device and Combination Product development Services to an industry leading Client base.
The QA Manager will be a key person in the ensuring quality assurance deliverables within a medical device Services organization. This role is responsible for ensuring that the QMS delivers products and services compliant with all relevant regulations, effectively and efficiently to Client requirements. The QA Manager will collaborate with cross-functional teams including R&D, Regulatory Affairs, and Project Management to maintain and improve quality systems, implement corrective actions, and guide continuous improvement initiatives.

Please send your resume and a cover letter to career@edgeonemedical.com and include QA Manager in the Title.

Essential Duties and Responsibilities

Quality Management System (QMS) Oversight:

  • Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
  • Define and establish performance standards and best practices within the Quality Management System (QMS).
  • Ensure that all QMS procedures, documents, and records are up to date and properly controlled.
  • Lead the continued transition from a paper-based system to an electronic Quality Management System (eQMS).
  • Contribute to the preparation and reporting of key performance indicators (KPIs) and management reports.
  • Lead internal and external audits, ensuring compliance and readiness for regulatory inspections.

Regulatory Compliance:

  • Ensure that medical devices and combination products developed by the organization meet regulatory requirements for safety, effectiveness, and quality.
  • Stay updated on changes to regulations, standards, and guidelines (e.g., FDA, MDR, IVDR, ISO) and communicate these to relevant teams.

Supplier and Vendor Management:

  • Collaborate with operational supply chain counterparts to qualify new suppliers and manage ongoing supplier performance.
  • Conduct audits and assessments of suppliers and vendors to ensure they meet the required quality standards for medical device development.

Document Control and Risk Management:

  • Oversee document control processes, ensuring proper documentation of all processes, procedures, test reports, and validations.
  • Implement risk management practices to ensure a risk-based approach is embedded in the QMS.

Non-Conformance, CAPA, and Continuous Improvement:

  • Investigate product and process non-conformances, root cause analysis, and drive corrective and preventive action (CAPA) programs.
  • Implement continuous improvement initiatives to enhance service quality and operational efficiency.
  • Lead cross-functional teams in problem-solving efforts to improve effectiveness efficiency, and Service quality.

Leadership:

  • Mentor and train the organization in Quality Assurance, ensuring they are fully equipped with the skills and knowledge to meet quality objectives.
  • Foster a culture of quality awareness and accountability across the organization.

Client Interaction and Project Support:

  • Act as the leading point of contact for QA-related queries from clients, providing guidance on compliance and quality issues.
  • Provide QA support during client projects, ensuring that client requirements are understood and integrated into the quality processes.

Training and Development:

  • Develop and implement training programs related to quality assurance, regulatory compliance, and product quality for both internal teams and external clients as needed.

Product Development Support:

  • Collaborate with R&D teams during the design and development phases to ensure products are developed in compliance with design controls (21 CFR Part 820, ISO 13485).

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Required skills/qualities/experiences:

  • Bachelor’s degree in engineering, life sciences, or a related field.
  • Minimum of 7+ years of quality assurance experience in the medical device industry, with at least 2-3 years in a senior role.
  • ISO 13485 Lead Auditor Certification, Six Sigma (Green/Black Belt), or similar certifications are desirable.
  • Strong understanding of medical device regulations, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR/IVDR.
  • Solution or industry specific benefit

Preferred Experience:

  • Proven experience with QMS implementation and management.
  • Strong problem-solving skills with experience in CAPA, non-conformance, and root cause analysis.
  • Excellent communication and leadership skills.
  • Ability to work cross-functionally and collaborate with diverse teams.
  • Attention to detail and strong organizational skills.

Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.