Principal Supplier Quality Engineer

integer; Chaska (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Integer is seeking a strategic Quality Engineer leader to guide supplier quality initiatives across the organization. You will apply deep engineering knowledge and QA principles to ensure product quality from supplier to final assembly.

You will manage supplier audits, non-conformances, and change notifications, mentor engineers, and drive continuous improvement in collaboration with Supply Chain, Manufacturing, and Engineering teams.

Responsibilities

• Provide strategic quality guidance across Integer to meet production quality goals.
• Manage supplier non-conformances, audits, and corrective actions to prevent re-occurrence.
• Lead supplier quality documentation, change notifications, and supplier quality agreements.
• Collaborate with Suppliers, Management, Supply Chain, Engineers and Manufacturing on capability studies and SPC techniques.

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.

Specific Supplier Quality responsibilities:

• 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