Sr. Engineer, Quality

As the Sr. Engineer, Quality at Axogen, you play a pivotal role in ensuring the quality and compliance of our healthcare products. Your responsibilities include evaluating product designs, leading quality planning activities for new developments, and resolving quality issues by applying your engineering expertise. You will also engage in risk management, collaborate with internal and external teams, and investigate manufacturing processes to enhance compliance and create a safer healthcare environment.

To become a Sr. Engineer, Quality at Axogen, you need a Bachelor’s Degree in Biomedical or Mechanical Engineering, or Engineering Technology. Additionally, you should have a minimum of 5 years in a Quality Engineering role within medical device or pharmaceutical manufacturing. Certifications such as ASQ CQE or Six Sigma Green Belt are preferred. Strong project management and communication skills are essential, as you will be working closely with various departments to ensure product quality.

At Axogen, we believe in fostering the professional growth of our employees, including the Sr. Engineer, Quality. We offer educational assistance, access to industry-related workshops, and opportunities to engage in knowledge-sharing networks. Our supportive team culture encourages you to pursue personal and professional development, making it easier for you to advance your career while making a meaningful impact.

The work environment for a Sr. Engineer, Quality at Axogen is collaborative, friendly, and dynamic. Our team values unique perspectives and fosters a culture of open communication. You will have the opportunity to work on different projects while contributing to significant advancements in healthcare. With a hybrid work schedule and flexible hours, Axogen prioritizes your work-life balance, making it an enriching place to grow your career.

As a Sr. Engineer, Quality at Axogen, you can enjoy a comprehensive benefits package that includes health, dental, and vision insurance from day one. Additional benefits include a matching 401(k) plan, paid time off, paid parental leave, tuition reimbursement, and an Employee Stock Purchase Plan. We also offer a supportive work environment that encourages personal well-being and professional development.

When answering this question, emphasize any systems you have worked with, such as ISO 13485 or FDA regulations. Discuss your familiarity with risk management processes, audits, and quality control measures you've implemented or improved. Provide specific examples of how these experiences contributed to product quality and compliance.

Highlight your understanding of risk assessment methodologies such as FMEA or root cause analysis. Discuss specific examples where you identified potential risks in projects and how you addressed them to ensure quality outcomes. This showcases your proactive mindset and your problem-solving abilities.

Use the STAR method (Situation, Task, Action, Result) to structure your answer. Briefly outline the issue, your specific role in addressing it, the actions you took to resolve it, and the results of your actions. This helps interviewers understand your problem-solving skills and your impact on the organization.

Discuss specific statistical tools you have utilized, such as Minitab or Excel, and describe how you have applied statistical methods to analyze data trends. Explain how this analysis has assisted you in identifying quality issues and implementing solutions. This shows your technical skills and analytical capabilities.

Emphasize the importance of collaboration across departments, such as product development, clinical, and manufacturing teams. Provide examples of successful communication strategies you've implemented in past roles that facilitated teamwork and quality improvements. This demonstrates your ability to work cross-functionally and lead quality initiatives.

Discuss your experience in leading quality planning activities by outlining your process for developing verification and validation plans. Highlight your knowledge of relevant standards and regulations as they pertain to new product development. Your response should reflect a forward-thinking approach that prioritizes patient safety and compliance.

Detail your understanding of design controls, including how they help ensure that product designs meet user needs and regulatory requirements. Discuss how you’ve implemented these controls in prior projects to bolster quality assurance and improve outcomes. This showcases your expertise in quality engineering.

Share specific instances where you collaborated with suppliers to enhance product quality. Discuss how you approached the situation, the communication strategies you employed, and the outcomes. This highlights your ability to forge strong partnerships and ensure compliance.

Explain your commitment to continuous learning through attending workshops, reading industry publications, and participating in professional societies. Illustrate how staying informed has directly benefited your practices in quality engineering in previous positions. This highlights your dedication to excellence and staying ahead in your field.

Discuss your belief in the importance of teamwork in ensuring product quality. Provide examples of how you have fostered a collaborative culture within engineering teams and across departments to achieve shared goals. This response emphasizes your interpersonal skills and leadership qualities.