Quality Systems Engineer III

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.

• You will select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes.
• You will lead cross functional teams or projects with minimal resource requirements, risk or complexity and may begin developing the skills to influence others to achieve goals.
• You will develop new and unique approaches to challenging problems and work on projects that advance Integer’s quality systems.
• You will originate new documents such as procedures, work instructions and reports to meet quality system requirements. You may also review documentation from peers and others.
• You will perform work on technical projects where you will follow Integer’s standard quality management methodologies to investigate opportunities for quality process improvements.
• You will apply standard data analysis practices and techniques to establish root cause for quality system issues.
• 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 are responsible to support internal and external audits. Provides support for external regulatory inspections and customer audits.
• Support the timely response and closure of audit observations and findings and reviews and maintains corrective actions from audit findings.
• You may be required to achieve a lead auditor status.

• You are responsible for assisting in preparing, coordinating, and documenting the sites Quality Management Review.

• You provide tracking and support for customer notifications.
• You provide Quality Systems and Compliance consulting related to CAPA, Complaint Investigations, and other compliance topics.
• You provide support for CAPA and NCR investigations as needed to insure timely and accurate processing.
• You complete trending and evaluation of data for quality system metrics.

• You embed quality within your daily work life – "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), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma.
• Assists with quality assurance functions in support of needs directed by Quality Management.
• Performs other duties as required.

• 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…