Associate Quality Systems Engineer

Job Title

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 We Are:

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM's to enhance the lives of patients worldwide and 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.

The primary purpose of this position is to support compliance to the Integer Quality System. As an entry level associate, you will ensure that Integer's Quality System Requirements are met or exceeded with the direction, instruction and guidance from more experienced associates and managers in your organization. You will learn compliance to the quality system requirements to ensure the company meets internal, regulatory and customer requirements.

General Quality System Support and

Collaboration:

• Under the supervision of experienced quality engineering mentors and managers, you will select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes.
• 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.

Audit Support:

• 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.

Management Review Support:

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

Issue Resolution Support:

• 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.

Additional:

• 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 corre ctive and preventive actions, and contributing to the successful attainment of our quality KPI's and journey to differentiated quality.
• Assists with quality assurance functions in support of needs directed by Quality Management.
• Performs other duties as required.

Provide support of 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 journey to differentiated quality.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Standardization…