Quality Systems Engineer III

integer; Chaska (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

Integer is seeking a Quality Systems Specialist to support and improve our Quality Management System across multiple sites in Minnesota. You will participate in internal and external audits, drive CAPA investigations, and collaborate with cross-functional teams to ensure quality KPI attainment and compliance with 5 Sigma objectives.

You will apply standard quality engineering methods and develop procedures, work instructions, and reports.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years of progressive engineering or technically focused roles.

Responsibilities

• Select and apply standard quality engineering techniques to adaptations of products and processes.
• Lead cross functional teams or projects with minimal resources and risk.
• Develop new approaches to challenging problems and advance Integer's quality systems.
• Originating documents to meet quality system requirements and review peers' docs.
• Investigate opportunities for quality process improvements using standard data analysis.
• Collaborate with others and communicate to support engineer development.

Skills

Quality engineering

Data analysis

Root cause analysis

Cross-functional collaboration

CAPA

Education

Bachelor's degree in engineering

Tools

QMS software

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

General Quality System Support and Collaboration:

• 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.

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.
• You may be required to achieve a lead auditor status.

Management review Support:

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

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 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 - Achievement of site Quality KPI's
• Innovation and ideation are critical aspects of your role

What sets you apart:

• Minimum Education: At a minimum you have earned a bachelor's degree in an engineering or related field and may have earned and master's degree.
• You are technically seen as a very competent technical contributor, a recognition you have earned through 5+ years of progressive engineering and/or technically focused roles and experiences.
• Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.
• You have a strong technical and problem