Quality Systems Engineer III

Integer Holdings Corporation•Chaska, MN

24d

About The Position

The Quality Systems Engineer III supports Integer’s quality systems and manufacturing excellence strategies. The role applies quality engineering methods to adapt and improve existing products and processes, investigate quality-system issues, develop documentation, and contribute to continuous improvement. It leads cross-functional teams or projects of limited complexity and collaborates with colleagues to exchange information and develop engineering capabilities. The position supports internal and external audits, regulatory inspections, customer audits, corrective actions, site Quality Management Reviews, customer notifications, CAPA and nonconformance investigations, and quality-system metrics. It also supports site plans and quality improvement initiatives, change notifications, workplace organization and visual controls, standard work, training and certification, standardized problem solving, and process optimization. The engineer is expected to uphold Integer’s Quality Management System, support quality KPIs and the journey to 5 Sigma, and actively support Environmental, Health and Safety programs. Success is assessed through safety, adherence to Integer’s values, achievement of defined goals and milestones, site Quality KPI results, and innovation and ideation. The role requires an experienced technical contributor who can work independently and with cross-functional teams, lead team activities, coach less experienced associates, communicate professionally across the organization, and remain composed in a changing work environment.

Requirements

Bachelor’s degree in engineering or a related field; candidates who do not meet the education requirement may be considered with 10 or more years of relevant experience.
At least 5 years of progressive engineering and/or technically focused roles and experience; candidates without the stated education may be considered with 10 or more years of relevant experience.
Strong technical and problem-solving foundation.
Ability to observe, analyze, and develop solutions to challenging technical issues and deliver 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 minimum; Black Belt preferred.
Ability to influence others to achieve goals.
Lead auditor status, which may be required.

Responsibilities

Select and apply standard quality engineering techniques, procedures, and criteria to adapt or 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.
Investigate opportunities for quality-process improvement using Integer’s standard quality management methodologies.
Apply data analysis practices to establish root causes of quality-system issues.
Support internal and external audits, regulatory inspections, and customer audits; help respond to and close audit observations and findings and maintain related corrective actions.
Assist with 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 NCR investigations to ensure timely and accurate processing.
Trend and evaluate data for quality-system metrics.
Uphold 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 site Hoshin Plans, Quality Plans, validation master plans, quality improvement imperatives, and regular updates to QA/RA weekly and monthly metrics.
Help ensure customer change notifications are initiated and completed, and support continuous improvement activities.
Support workplace organization and visual controls (5S), Manufacturing Standard Work, and applicable training and certification programs.
Promote associate engagement through standardized problem-solving methods, behavior-based safety programs, and improvement idea and suggestion systems.
Support optimization of systems and processes through built-in-quality principles.
Actively support Integer Environmental, Health and Safety programs and adhere to Integer values.
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 after one year.
Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
401(k) plan with company matching contributions; employees are immediately eligible.
80 hours (10 days) of company-designated holidays per year.
Annual allotment of paid time off.