This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s goals and objectives as it relates to quality.
The Quality Manager is responsible for ensuring that all processes needed for the quality management system are effectively established, implemented, and maintained including: CAPA, training, internal audit, quality review, supplier management, serving as alternate (i.e. deputy) management representative, document control, complaint handling, adverse event reporting, and trending. Assess and continuously improve the Aziyo (Roswell) quality management system.
Position reports to Sr. Director, Quality
Essential Duties & Responsibilities
- Responsible for managing and guiding Quality Systems Complaint Analyst and ensuring the effective management and handling of complaints, adverse event reporting, and complaint trending. Responsible for Post Market Surveillance activities and reporting on product performance.
- Responsible for ensuring the effective management of the electronic document control system and the successful configuration, implementation, and maintenance of Grand Avenue software modules. Ensure that the requirements of all regulated processes are met and that appropriate documentation is maintained per regulatory requirements and Good Documentation Practices.
- Provides guidance and leadership, as required, in the qualification of new product transfers from Design Control and manufacturing processes including equipment qualification, packaging development and qualification, sterilization validation, and product stability programs.
- Utilize quality engineering techniques and practices to ensure that the Aziyo products designed, tested, manufactured and ultimately distributed meet or exceed their intended performance requirements and these products are safe and efficacious for their intended use.
- Ensure the adequacy and appropriateness of the company’s training system. Ensure company personnel are adequately trained in the implementation of the quality system and are in compliance with the respective regulations and internal procedures.
- Assists Quality Management during all Notified Body/FDA, or other regulatory agency audits, inspections and follow-up.
- Assists Quality Management for timely Corrective and Preventative Actions (CAPA), conducting failure and quality investigations as needed, ensuring internal and vendor audits conducted per schedule and assist in product release, device history records, and device master records review as required.
- Ensure that the GA facility remains in compliance with all applicable regulations and requirements in which Aziyo manufactures products (FDA Parts 803, 820, TGA, EU MEDDEV 93/42 / MDR Regulation (EU) 2017/745, UK MDR 2002, etc).
BS in Engineering or Science degree, or equivalent experience, with minimum 5-7 years of Medical Device Experience (regulatory affairs of quality management systems experience preferred).
Experience and Skills
Work Experience Required:
- Equivalent combination of education and experience, with 5-7 years of Medical Device Experience.
- Experience in manufacturing quality (production, packaging, labeling incoming and shipping, critical systems, etc.).
- Experience in FDA/ISO/Notified Body interactions/audits
- Electronic document handling experience preferred.
- Statistical Software (e.g. experience with StatGraphics, MiniTab, or StatEase).
Specialized Skills, Knowledge:
- Good working knowledge of medical device manufacturing requirements and FDA QSR’s (21 CFR 820), ISO 13485, and ISO 14971 compliance guidelines.
- English Language skills.
- Advanced computer skills (e.g. experience with Microsoft Word, Excel and PowerPoint).
- ASQ Certification desired, Certified Quality Engineer (CQE) and/or Certified Quality Auditor preferred.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.
Connect with Us
Stay up-to-date on our latest developments by connecting with us on LinkedIn.
1. Citations go here