Quality Analyst (2nd Shift)

As a Quality Analyst at Axogen, you'll engage in quality control inspections of medical devices and human tissue products. Your key responsibilities will include reviewing batch production records, managing non-conforming reports, and performing in-process inspections. You’ll also be involved in CAPA processes and ensure compliance with all regulatory standards.

To apply for the Quality Analyst role at Axogen, candidates are expected to have a Bachelor’s Degree in a Life Science discipline or a related field, with a preference for those holding a degree in engineering. Additionally, 0-2 years of relevant industry experience within a Medical Device or Pharmaceutical organization is desired.

At Axogen, we are committed to fostering professional growth. We provide educational assistance, a comprehensive benefits package from day one, and opportunities for hands-on experience in a supportive team culture that values unique perspectives and encourages continuous learning.

The work environment for a Quality Analyst at Axogen is collaborative and dynamic. You will be part of a friendly, open team culture where your contribution to quality assurance directly impacts patient care. Our flexible working hours also promote a balanced work-life routine.

As a Quality Analyst at Axogen, you can anticipate an attractive benefits package that includes health, dental, and vision coverage, a matching 401(k) plan, paid time off, tuition reimbursement, and opportunities for stock purchases, among other perks that support your overall well-being.

When conducting a quality control inspection, it's important to familiarize yourself with the specific standards and specifications of the products. Begin by preparing the necessary tools and documents, then follow a structured process to systematically examine the materials. Document your findings meticulously to ensure accuracy and compliance with Axogen’s Quality System.

In the interview, emphasize any experience you have within FDA-regulated environments. Discuss how you have previously ensured compliance with quality standards, managed documentation, and participated in quality audits. Being knowledgeable about the regulations will reassert your qualifications for the Quality Analyst position at Axogen.

Share specific methodologies you’re familiar with, such as the '5 Whys' or failure mode and effects analysis (FMEA). Explain how you would gather data, collaborate with teams, and use your analytical skills to identify and address the root causes of quality issues effectively.

Discuss any relevant experience you have in handling NCRs, detailing how you record, manage, and follow up on each case. Provide an example of a corrective action you implemented, highlighting the steps taken to prevent recurrence and how you ensured compliance with Axogen standards.

Explain your approach to prioritizing tasks based on urgency and impact on product quality. Discuss how you utilize tools like checklists or project management software to stay organized, ensuring you meet deadlines and maintain an efficient workflow at Axogen.

If you have direct experience with environmental monitoring, discuss your roles in planning and executing such programs. Highlight your attention to detail in testing and data analysis to ensure compliance with quality standards at Axogen.

Provide a specific example of a challenging quality issue, outlining the context, challenges faced, and actions taken. Be sure to describe the positive outcomes that resulted from your resolution, reflecting your problem-solving abilities as a Quality Analyst.

Discuss any relevant software experience you have, particularly with Microsoft Excel or quality management systems. Explain how you've utilized these tools to track documentation, analyze data, or streamline quality processes in your previous roles.

Highlight the significance of Good Documentation Practices and how you adhere to them in your previous roles. Discuss techniques such as regular audits, thorough documentation of processes, and ensuring everyone on the team is trained in GDP.

In your response, emphasize the importance of attention to detail and integrity. A Quality Analyst must be diligent and committed to maintaining high standards, as the quality of products directly impacts patient outcomes and the reputation of Axogen.