Quality Engineer Ii

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?**

**What you’ll do in this role**:

- 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 will support 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 participate in continuous improvement projects.
- You will assist with 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.

**_ 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 validations and capability studies. Recommends process monitoring devices where applicable.
- You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process and Final Inspection procedures.

**_Support Non-Conforming Material Process:_**
- You will ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
- You will lead and manage complaint investigations.
- You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Support Site Quality Activities:_
- You will support internal quality audit activities, as applicable
- You embed Quality
- “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), supporting to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality.
- You may perform other duties as needed and as directed by your line of supervision.

**_ Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies:_**
- **Strategy Alignment** through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives, and regular updates to QA RA weekly and monthly metrics, supporting the walk to 5 sigma.
- **Leadership of Sustained Change** ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
- **Standardization**through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
- **Associate Engagement** promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
- **Systems & Process Optimization** through adoption of principles of built-in-quality

**How you**will be measured**:

- Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
- Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation
- You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
- Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time
- Innovation a