Manager, Quality Engineering

Nordson; Easton (Northampton County); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Engineer to lead quality initiatives in a collaborative environment. This role emphasizes quality leadership, customer engagement, and compliance with regulatory standards in the medical device sector. You'll have the chance to influence product quality and operational efficiency while working with a diverse team committed to innovation and excellence. If you're passionate about quality and eager to make a difference in healthcare, this opportunity is for you!

Qualifications

• Minimum 5 years of experience in Quality Control/Assurance.
• Experience with ISO 13485 and FDA regulations.
• Prior supervisory experience preferred.

Responsibilities

• Provide quality leadership and drive quality objectives.
• Ensure compliance with ISO standards and FDA regulations.
• Manage customer complaints and CAPA investigations.

Skills

Analytical Skills

Problem-Solving Skills

Statistical Analysis

Quality Engineering

Customer Service

Education

Bachelor’s Degree in Engineering

ASQ Certified Quality Engineer

Six Sigma Black Belt Certification

Tools

Microsoft Office Suite

Minitab Statistical Software

Job description

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

1. Provide Quality leadership by partnering with the site operations leader and/or General Manager to plan and drive quality objectives that support business goals.
2. Represent the site and quality program through excellent customer service, ensuring responsiveness and engagement to make Nordson MEDICAL the customer's supplier of choice.
3. Offer leadership and expert guidance in technical quality areas including quality engineering, product and process quality, and new product introductions.
4. Promote a quality culture while improving operations related to on-time delivery (OTD) and cost of poor quality (COPQ).
5. Champion the FOCUS Quality Operating System.
6. Prioritize quality engineering and QC work in line with production priorities and business needs to maintain efficient product flow through QC checkpoints.
7. Ensure resources are allocated to execute projects, inspections, and tests in compliance with the QMS, meeting or exceeding customer expectations.
8. Procure and maintain calibration of inspection, measurement, and test equipment.
9. Assess training needs for quality engineering and QC teams and coordinate or deliver necessary training, cross-training, and coaching.
10. Ensure adherence to all company policies, procedures, standards, and safe work practices.
11. Develop a talent strategy focused on empathy, integrity, inclusion, learning, and collaboration to build effective teams.
12. Promote a culture aligned with Nordson values and Foundational Attributes.
13. Coach team members for development and manage performance and behavioral concerns promptly.
14. Plan quality resources to reduce overhead costs and align resources with business priorities.
15. Serve as ISO and CFR management representative for the QMS, providing regular reports to the site General Manager and NM Corporate Quality.
16. Lead and promote improvements and lean initiatives to enhance QMS efficiency and compliance.
17. Act as liaison with customers regarding the QMS, including customer quality agreements, specifications, audits, first article requests, validation, and change requests.
18. Ensure compliance with ISO 13485, FDA CFR Part 820 (QSR), and other relevant standards and regulations.
19. Manage the NC process, including product segregation, investigation, documentation, and disposition approval.
20. Lead customer complaints and CAPA investigations.
21. Contribute to continuous improvement activities supporting business goals.
22. Develop sampling techniques for testing results and ensure DHR reviews are completed.
23. Maintain accurate record-keeping to meet GDP and regulatory requirements.
24. Communicate with customers to support investigations and new product development.
25. Support new product development by developing inspection and test methods.
26. Assist with internal, customer, and supplier audits, and document control as needed.
27. Collaborate with engineering, operations, and other functions to execute QC tasks aligned with site priorities.
28. Promote data-driven decision making by maintaining ERP data and reporting metrics to leadership.
29. Perform other duties as assigned.

Required Education and Experience

• Bachelor’s Degree in engineering or a related quality field.
• ASQ Certified Quality Engineer is a plus.
• Six Sigma Black Belt Training and/or Certification preferred.
• Minimum 5 years of experience in Quality Control/Assurance or a similar technical role.
• Experience with medical device quality systems (ISO 13485) and US FDA Quality System Regulation (21 CFR 820).
• Prior supervisory experience preferred.

Knowledge, Skills & Abilities

• Proficient in Microsoft Office suite.
• Working knowledge of Minitab Statistical Software.
• Strong analytical and problem-solving skills, including statistical analysis and DOE.

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Interested?

If you are interested in joining our team and contributing to an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are experts in designing, developing, and manufacturing complex medical devices and components. Join us to bring innovative ideas to life and help create life-saving medical devices. We offer a supportive culture and opportunities for career growth in a dynamic environment. Whether starting your career or a seasoned professional, there's a place for you at Nordson MEDICAL. We provide various positions across production, maintenance, customer service, quality, engineering, and more. We invest in our teams to help you build your skills and advance your career.