Senior Quality Engineer

Overview

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 OEMs to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. 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.

The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. The following are expectations:

• Ensure Integer internal and external customer expectations are met or exceeded. You identify and evaluate procedures to ensure the production of quality product.
• Develop new and unique approaches to complex problems and 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 field.
• Adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: QMS, Safety, Environmental and Security Management Systems, FDA regulations, company policies and operating procedures, and other regulatory requirements.
• Manufacturing Support: monitor regulatory and agency inspections, audits, investigations, and inquiries regarding control and assessment of product design and manufacturing quality.
• Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and ensuring complete and correct Device History Records are maintained.
• Review the adequacy and correctness of changes to BOMs, Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc.
• Lead in continuous improvement projects and product transfers.
• You may provide supervision for up to 3 engineering direct reports, and act as a coach and mentor for other engineers.
• Perform work on technical projects following Integer’s standard QMS and production system methodologies to investigate opportunities for product and process improvements.
• Collaborate with others, exchange information, ask questions, and regularly check for understanding in support of development as an engineer.

• Lead the generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies; recommend process monitoring devices where applicable.
• Develop various inspection techniques and procedures to ensure product integrity to design specifications; responsible for writing, approval and implementation of incoming, in-process and final inspection procedures.

• Ensure disposition of non-conforming materials meets all procedures and ensure adequacy of corrective actions to prevent re-occurrence.
• Lead and manage complaint investigations and CAPA activities, including data analysis and root causes.
• Lead plant CAPA activities and engage with suppliers, management, engineers and…