Principal Quality Engineer
ExternalPrepare for this interview
EliteAI-generated questions, company research, and talking points tailored to this role
Benefits
Additional Information
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 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 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. Manufacturing Support: You are recognized as a subject matter expert within Integer and challenged to solve unique and complex problems that have a broad impact on the business. You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. You will monitor manufacturing of assigned products, 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), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. You will lead continuous improvement projects. You will lead product transfers. 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. You may provide supervision for up to 4 to 5 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 provide direction and administrative organization for the design and engineering services departments and set priorities for utilization of resources on new projects or programs. You interact with a global customer base and are responsible for interface/travel for customer interaction and communication. As such, you work closely with customers and sales management to establish, maintain, and improve relationships. Your skills and experiences are leveraged to discover and promote new business and market opportunities as well as production performance improvements. Create Test Methods: You will lead the generation and completion of protocols and reports for test method validations. You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process valida
Your Match
How well this role fits your profile.
Company Intel
What employees say
Worked at integer? Share your experience