Quality Engineer.
Position Overview.
Who We Are
We’re a team with a shared purpose to bring innovative solutions to physicians and patients around the globe. What we do or don’t do each day affects the lives of patients and that’s why we are dedicated to the development of our employees who work collectively to achieve our goals.
What Are We Doing in Richmond, CA?
We process human tissue to produce high-quality allografts for transplantation. These allografts are used in medical and surgical procedures to help physicians and their patients address a variety of medical conditions.
Our Team
Our Team operates in accordance with Aziyo’s established standard operating procedures (SOPs). Every member is a key part of the process to ensure each donor’s Gift is honored by ensuring the highest level of performance and seeking continual improvement opportunities to optimize its usage. This is why we are seeking an experienced Quality Engineer with a strong background in Quality Assurance, to join our team.
The Quality Engineer
The Quality Engineer will play a vital role in ensuring our tissue processing and distribution operations meet the highest quality standard. This includes designing and implementing Quality procedures, ensuring supplier quality, investigating Quality events, analyzing data to identify areas for improvement, and ensuring compliance with all regulatory requirements.
The ideal Quality Engineer will possess a strong commitment to Quality, attention to detail, critical thinking and problem solving skills and the drive to understand and improve processes and systems. This individual has a Quality mindset and encourages the same with team members throughout the organization.
What We Value:
- Dedication to Quality – Our Quality team members are critical in ensuring that every Aziyo product that is delivered to our customers exceeds standards and meets regulatory requirements.
- A Sense of Purpose – We value the Gift of tissue donation, and our success is attributed to the like-minded individuals who work with these donations to improve patient outcomes globally and are proud to be part of something bigger than themselves.
- Innovative Solutions – We value the ability to think critically and creatively to identify problems and develop effective solutions. Our team members are ever-evolving, agents of growth who are committed to continuous improvement.
Essential Duties & Responsibilities
- Assists Quality Management during regulatory and customer audits, inspections and assists with inspection follow-up as needed.
- Maintain supplier quality system and perform supplier audits as needed to ensure supplier quality and compliance with regulatory requirements
- Perform investigation and closure of out of specification events, customer complaints, deviations and corrective and preventative actions (CAPA)
- Analyze data and trends to identify areas for improvement in tissue processing and distribution.
- Assist with regulatory filings, including registration, licensing, and accreditation with various regulatory agencies (FDA, AATB and state agencies)
- As needed, participate in a variety of Quality activities in support of Operations, including incoming material inspections, in-process product inspections/evaluation, record review and product disposition
- Conduct internal audits to ensure compliance with quality procedures and regulations
- Participate in the development and implementation of training programs for Quality and other personnel
Education
- BS in Engineering or Science degree
Experience and Skills
- 3+ years of Quality experience in a relevant industry
- Experience in tissue banking or related industry preferred.
- Knowledge of FDA and AATB regulations.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong attention to detail and ability to multitask.
Physical Requirements
- Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
- Ability to distinguish colors.
Apply Now.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.
Connect with Us
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