Associate Quality Systems Engineer

integer; Plymouth (MN); On-site; USD 52,000 - 70,000; Full time

Job summary

Integer seeks an entry level quality associate to support the company quality system and ensure compliance with QMS, safety, environmental, and regulatory requirements. You will learn and apply quality engineering techniques under guidance from mentors and managers, contributing to audits and process improvements.

Responsibilities include assisting in audits, CAPA, NCR investigations, and data trending, while embedding quality in daily work and supporting corrective actions to achieve key

Responsibilities

• Support internal and external audits.
• Provide support for external regulatory inspections and customer audits.
• Assist in preparing, coordinating, and documenting the site Quality Management Review.
• Provide tracking and support for customer notifications.
• Provide Quality Systems and Compliance consulting related to CAPA, Complaint Investigations, and other compliance topics.
• Assist with CAPA and NCR investigations as needed to ensure timely processing.
• Complete trending and evaluation of data for quality system metrics.

Job description

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.

What you will do in this role:

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.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.

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 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