Quality Systems Engineer III

General Quality System Support and Collaboration

• Select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes.
• 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.
• Develop new and unique approaches to challenging problems and work on projects that advance Integer's quality systems.
• Originate new documents such as procedures, work instructions and reports to meet quality system requirements. May also review documentation from peers and others.
• Perform work on technical projects following Integer's standard quality management methodologies to investigate opportunities for quality process improvements.
• Apply standard data analysis practices and techniques to establish root cause for quality system issues.
• 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

• Support internal and external audits.
• Provide support for external regulatory inspections and customer audits.
• Support the timely response and closure of audit observations and findings and review and maintain corrective actions from audit findings.
• May be required to achieve a lead auditor status.

Management Review Support

Assist in preparing, coordinating, and documenting the site's Quality Management Review.

Issue Resolution Support

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

Additional Responsibilities

• Embed Quality within daily work life – 'I own Quality.' Be a standard bearer for Quality by assuring adherence to the Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of quality KPIs and journey to 5 Sigma.
• Assist with quality assurance functions in support of needs directed by Quality Management.
• Perform other duties as required.

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 KPIs.
• 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 a 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-solving foundation, and preferably training and certifications, in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred).
• Your abilities to observe, analyze and develop solutions to challenging technical issues result in the delivery of measurable results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.
• You work independently as well as collaboratively with cross functional teams.
• You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.
• Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
• You maintain a calm demeanor that transcends the high energy, constantly changing work environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.