Quality Engineer

The Quality Engineer at Nextern is tasked with managing quality requirements and ensuring that customer quality expectations are not only met but exceeded. Key responsibilities include leading CAPA investigations, performing internal audits, leading QMS document changes, and executing critical reports like IIR and FAIR. They also support quality activities during new product introduction and collaborate with various engineering areas, all while mentoring others in quality tools and techniques.

To apply for the Quality Engineer position at Nextern, candidates should possess a bachelor's degree in engineering or a life sciences-related field, and preferably a postgraduate degree in related areas. Additionally, applicants should have a minimum of 5 years of experience in a quality engineering role within a highly regulated manufacturing environment, alongside proficient English language skills (C1 or B2 level).

Success as a Quality Engineer at Nextern relies on strong analytical and problem-solving skills, particularly in conducting root cause analysis and leading investigations. Excellent communication skills are essential for interacting with various stakeholders. Additionally, the ability to build collaborative relationships and demonstrate operational excellence is critical. Proficiency in quality management systems and a solid understanding of regulatory standards will also benefit candidates significantly.

Yes, experience in a highly regulated manufacturing or industry environment is essential for the Quality Engineer role at Nextern. Candidates should have at least 5 years of relevant experience that demonstrates their ability to navigate regulatory standards and ensure compliance while managing quality assurance processes.

The work environment at Nextern is supportive and focused on continuous improvement and professional development. Quality Engineers can expect a collaborative atmosphere where they have the resources and support to excel in their roles. Nextern values operational excellence and innovation, ensuring that employees have an optimal working environment that encourages growth and engagement.

When answering this question, highlight specific CAPA investigations you've led in the past. Discuss your process for identifying root causes, developing action plans, and verifying the effectiveness of the implemented solutions. Emphasize any tools and methodologies you used that align with industry best practices.

In response to this question, outline your approach to internal audits, including how you prepare, gather data, and evaluate compliance with regulations and standards. Discuss your ability to engage team members in the process and any metrics you may track to assess the effectiveness of audits.

Explain your communication style when dealing with external clients. Highlight the importance of transparency and proactive engagement. You can mention how you ensure that clients are kept informed of developments in investigations and the steps taken for resolution, always maintaining a professional and positive tone.

Choose a specific instance where you successfully led a change in QMS documents. Discuss the reasons for the change, how you collaborated with relevant stakeholders, and the outcomes of the process. It's also important to emphasize how you ensured that everyone understood and adhered to the changes.

Share your thoughts on challenges such as balancing regulatory compliance with operational efficiency or managing stakeholder expectations. Explain how you've navigated these challenges in past roles, emphasizing your problem-solving capabilities and commitment to quality.

Highlight your method for conducting root cause analysis by explaining the systematic approach you take, such as using the 5 Whys, Fishbone Diagram, or similar tools. Mention how you apply these findings to prevent future issues, showcasing your analytical thinking.

List the quality tools you are experienced with, such as Six Sigma, FMEA, or Statistical Process Control (SPC), and provide examples of how you've utilized these tools in various projects to improve processes and outcomes. Discuss the impact of these tools on achieving quality objectives.

Discuss your approach to mentoring junior staff, emphasizing your commitment to sharing knowledge and best practices. Provide examples of how you’ve guided them through complex investigations or quality-related tasks, fostering their professional development and confidence.

Prepare a specific example of a new product introduction where you contributed significantly to the quality assurance process. Detail your role, the challenges you faced, and how your efforts led to a successful launch, thus illustrating your value in similar future projects.

Answer this question by discussing your commitment to continuous learning—whether through formal education, attending industry conferences, or participating in professional organizations. Mention specific resources you rely on to keep abreast of new regulations and trends in the quality engineering field.