Principal Supplier Quality Engineer

integer; Chaska (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Integer, a global technology and manufacturing company, seeks a Supplier Quality Engineer to provide strategic quality guidance across supplier networks. You will lead audits, manage non-conformances, and drive improvements using DOE, Cpk, and hypothesis testing.

Responsibilities include reviewing BOMs, handling First Article Inspections, and mentoring engineering teams in quality practices within a regulated medical device context.

Qualifications

• Apply intensive and diversified knowledge of engineering principles in broad assignments and projects.
• Provide quality guidance to internal and external customers and stakeholders.
• Lead supplier QA activities, including audits and corrective actions when needed.

Responsibilities

• Provide strategic quality guidance supporting Integer's goals.
• Lead supplier audits and manage nonconformances and CAPAs.
• Oversee First Article Inspection and change notification processes.
• Review BOMs, drawings, FMEAs, and related quality documentation.
• Coach engineers and collaborate across functions on process improvements.

Skills

Supplier quality

Quality engineering

Audits

Statistical QC

DOE

Hypothesis testing

Cpk

CAPA

Document control

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

• Customer We focus on our customers' success
• Innovation We create better solutions
• Collaboration We create success together
• Inclusion We always interact with others respectfully
• Candor We are open and honest with one another
• Integrity We do the right things and do things right

Who are we?

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients worldwide. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

What you'll do in this role:

The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals. You will be applying intensive and diversifies quality knowledge and principles in extensive assignments and project leadership. As the authority in your field, you will provide guidance and quality leadership to others across Integer. The following are the expectations for this role:

• Apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.
• Ensure Integer internal and external customer expectations are met or exceeded. Identifies and evaluates procedures to ensure the production of quality product.
• Develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
• Apply engineering concepts to resolve acute or chronic problems.
• Conduct studies to understand capability for process and/or measurement systems. Provides management with technical guidance as required.
• Identify and develop appropriate documentation for process improvement and project implementation.
• Maintain liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed.
• You adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• You will manage supplier non-conformances, liaising with suppliers to ensure all issues are adequately addressed.
• You will manage and conduct supplier audits, tracking the closure of any audit related findings.
• You will lead the suppliers' product and process change notification system, as applicable.
• You will lead Supplier Quality Agreement management process with suppliers.
• You will work with Suppliers, Management, Supply Chain, Engineers and Manufacturing associates in the resolution of supplier quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
• You will be responsible for managing the sourced item qualification process and ensuring all appropriate documentation is completed.
• You will be responsible for managing the First Article Inspection process.
• You will monitor supplier related KPIs, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
• You will review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
• You will be supplier quality resource for any site continuous improvement projects.
• You will support product transfers.
• You may provide supervision for up to 3 engineering direct reports. As well, you will serve as a coach and mentor for other engineers, modeling the behaviors and disciplines of an engineering or technical professional.
• You will perform work on technical projects where you will follow Integer's standard quality management and production system methodologies to investigate opportunities for product and process improvements.
• You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.

Support Non-Conforming Material Process:

• You will ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures and assure adequacy of supplier corrective actions to prevent re-occurrence.
• You will lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material.