Quality Systems Engineer III

Integer•Chaska, MN

About The Position

The Quality Systems Engineer III supports and advances Integer’s quality systems by applying quality engineering methods, investigating quality issues, improving processes, and developing quality-system documentation. The role leads cross-functional teams or lower-complexity projects, collaborates with colleagues, and provides support for audits, management reviews, customer notifications, CAPA and nonconformance investigations, and quality metrics. It also supports Integer’s Manufacturing Excellence and Market Focused Innovation strategies through site plans, sustained change, standardization, associate engagement, and process optimization. The position is expected to uphold Integer’s values and Quality Management System, contribute to corrective and preventive actions and quality KPIs, and actively support Environmental, Health & Safety programs. The role requires a bachelor’s degree in engineering or a related field and at least five years of progressive engineering or technically focused experience; candidates without the education requirement may be considered with 10 or more years of relevant experience. The position calls for strong technical problem-solving, communication, collaboration, and team leadership skills. A master’s degree and relevant problem-solving or project-management training and certifications are noted as additional qualifications.

Requirements

  • Bachelor’s degree in engineering or a related field; candidates who do not meet this education requirement may be considered with 10 or more years of relevant experience.
  • At least five years of progressive engineering and/or technically focused experience, unless qualifying through the stated education alternative.
  • Strong technical and problem-solving foundation.
  • Ability to observe and analyze challenging technical issues and develop solutions that produce measurable results.
  • Ability to work independently and collaboratively with cross-functional teams.
  • Ability to lead team activities and coach less experienced associates.
  • Well-developed written and oral communication skills, including clear and professional communication at all organizational levels.
  • Ability to maintain a calm demeanor in a high-energy, constantly changing work environment.
  • Positive, can-do attitude.

Nice To Haves

  • Master’s degree.
  • Training or certifications in problem-solving and project-management methodologies, including Six Sigma Green Belt at a minimum; Black Belt preferred.
  • Potential to achieve lead auditor status.

Responsibilities

  • Select and apply standard quality engineering techniques, procedures, and criteria to adapt and modify existing products and processes.
  • Lead cross-functional teams or projects with minimal resource requirements, risk, or complexity.
  • Develop approaches to challenging problems and work on projects that advance Integer’s quality systems.
  • Create quality-system documents, including procedures, work instructions, and reports, and review documentation from peers and others as needed.
  • Conduct technical projects using Integer’s quality management methodologies to investigate quality process improvement opportunities.
  • Apply standard data-analysis practices to determine root causes of quality-system issues.
  • Support internal and external audits, regulatory inspections, and customer audits; help ensure timely responses to and closure of audit observations and findings, and review and maintain related corrective actions.
  • Assist in preparing, coordinating, and documenting the site Quality Management Review.
  • Track and support customer notifications.
  • Provide Quality Systems and Compliance consulting on CAPA, complaint investigations, and other compliance topics.
  • Support CAPA and nonconformance (NCR) investigations to ensure timely and accurate processing.
  • Trend and evaluate data for quality-system metrics.
  • Adhere to the Quality Management System, facilitate or contribute to corrective and preventive actions, and support quality KPIs and the journey to 5 Sigma.
  • Assist with quality assurance functions as directed by Quality Management and perform other duties as required.
  • Support strategy alignment through site Hoshin Plans, Quality Plans, validation master plans, quality improvement initiatives, and regular updates to QA/RA weekly and monthly metrics.
  • Support sustained change by ensuring customer change notifications are initiated and completed as necessary and by supporting continuous improvement activities.
  • Support standardization through workplace organization and visual controls (5S), Manufacturing Standard Work, and training and certification programs where applicable.
  • Promote associate engagement through standardized problem-solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
  • Support systems and process optimization through adoption of built-in-quality principles.
  • Actively support Integer Environmental, Health & Safety programs and adhere to Integer’s stated values.
  • Collaborate with colleagues, exchange information, ask questions, and check for understanding.
  • Lead team activities and coach less experienced associates.

Benefits

  • Base salary and cash-based incentive program.
  • Medical insurance.
  • Dental insurance.
  • Vision insurance.
  • Disability insurance.
  • Life insurance.
  • Adoption benefits.
  • Parental leave available after one year.
  • Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
  • 401(k) plan with company matching contributions; immediate eligibility.
  • 80 hours (10 days) of company-designated holidays per year.
  • Annual allotment of paid time off.
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