Quality Engineer III

Integer•Pembroke Pines, FL

About The Position

The Quality Engineer III applies broad and intensive engineering knowledge to quality, manufacturing, and process improvement assignments. The role works to meet or exceed internal and external customer expectations, evaluate procedures that ensure quality product, solve complex or recurring problems, assess process and measurement-system capability, and provide technical guidance to management. It develops documentation for process improvements and projects and may act independently on technical matters within and outside the organization. The role follows Integer’s values and applicable quality, safety, environmental, security, FDA, and other regulatory requirements. The engineer supports manufacturing quality and regulatory activities, including inspections and audits; monitors assigned product manufacturing for compliance with Device Master Records; provides deviation and waiver guidance; and ensures Device History Records are complete and correct. The role reviews changes to manufacturing and product documentation, leads continuous improvement projects, assists with product transfers, and works on technical projects using Integer quality and production system methodologies. The role leads test-method validation protocols and reports, coordinates process validations and capability studies with Manufacturing Engineering, recommends process-monitoring devices, develops inspection techniques, and writes, approves, and implements inspection procedures. It supports nonconforming-material disposition and corrective actions, leads complaint investigations, and participates in plant CAPA activities, including data analysis, trend review, and root-cause analysis. It also supports site audits and quality activities, quality plans and metrics, customer change notifications, standardization, associate engagement, and process optimization. The engineer is accountable for embedding quality in their work and contributing to quality KPIs and continuous improvement.

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 experience if meeting the stated education requirement.
Strong technical and problem-solving foundation.
Awareness of relevant domestic and international regulations and industry standards, such as ISO, QSR, UL, MDD, and TGA.
Good knowledge of Microsoft Office.
Solid technical aptitude and ability to contribute effectively to a team or produce technical results independently.
Competent written and oral communication skills; candidates outside the United States must demonstrate written and oral English communication skills.
Ability to maintain a calm demeanor in a high-energy, constantly changing production environment.
Positive, can-do attitude and an underlying belief that failure is not an option.
Adherence to Integer’s values and applicable quality, safety, environmental, security, FDA, company, and other regulatory requirements.

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.

Responsibilities

Ensure internal and external customer expectations are met or exceeded.
Identify and evaluate procedures to ensure production of quality products.
Apply engineering concepts to resolve acute or chronic problems and develop approaches to complex technical problems.
Conduct studies to understand process and measurement-system capability.
Provide technical guidance to management as required.
Develop documentation for process improvement and project implementation.
Support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
Monitor manufacturing of assigned products for compliance with the Device Master Record, provide deviation and waiver guidance, and ensure Device History Records are complete and correct.
Review changes to Bills of Materials, assembly procedures, drawings, component specifications, FMEAs, control plans, and related documentation.
Lead continuous improvement projects and assist with product transfers.
Use Integer quality management and production system methodologies to investigate product and process improvement opportunities.
Lead the generation and completion of test-method validation protocols and reports.
Coordinate process validations and capability studies with Manufacturing Engineers and recommend process-monitoring devices where applicable.
Develop inspection techniques and procedures and write, approve, and implement incoming, in-process, and final inspection procedures.
Ensure nonconforming-material dispositions meet applicable procedures and corrective actions are adequate to prevent recurrence.
Lead and manage complaint investigations and participate in plant CAPA activities, including data and trend analysis and root-cause analysis.
Use data analysis and observation to establish root causes of product and process failures or support improvement justifications.
Support internal quality audits and other site quality activities, as applicable.
Adhere to the Quality Management System and support corrective and preventive action investigations and implementation, quality KPIs, and the journey to 5 Sigma.
Support site Hoshin plans, quality plans, validation master plans, quality improvement initiatives, and QA/RA weekly and monthly metrics.
Ensure customer change notifications are initiated and completed as necessary and support continuous improvement activities.
Promote workplace organization and visual controls (5S), manufacturing standard work, training and certification programs, standardized problem solving, behavior-based safety, and improvement suggestions.
Support adoption of built-in-quality principles and collaborate with others to exchange information, ask questions, and check for understanding.
Support Integer Environmental, Health & Safety programs and contribute to continuous improvement suggestions and their implementation.
Perform other duties as needed and directed by the line of supervision.