Quality Engineer III

Integer Holdings Corporation•Pembroke Pines, FL

About The Position

The Quality Engineer III applies engineering principles and practices to a broad range of quality assignments, identifies and evaluates procedures to ensure production of quality products, and resolves complex product and process problems. The role studies process and measurement-system capability, provides technical guidance, develops documentation for process improvement and project implementation, and works independently on technical matters. The engineer follows Integer’s values and applicable quality, safety, environmental, security, FDA, company, and other regulatory requirements. The role supports manufacturing quality and regulatory inspections, audits, investigations, and inquiries; monitors assigned products for compliance with Device Master Records; provides guidance on deviations and waivers; and helps ensure Device History Records are complete and accurate. It reviews manufacturing documentation and changes, leads continuous improvement projects, assists with product transfers, and undertakes technical projects to improve products and processes. The engineer leads test-method validation protocols and reports, coordinates process validations and capability studies with Manufacturing Engineers, recommends process monitoring devices, and develops inspection techniques and procedures. Responsibilities also include managing non-conforming material dispositions and complaint investigations, participating in CAPA and root-cause activities, supporting internal quality audits, and contributing to site quality plans and metrics. The position supports Integer’s manufacturing excellence and innovation strategies through sustained change, standardization, associate engagement, and process optimization. Performance is assessed through safety and adherence to Integer’s values, defined goals and milestones, quality measures such as complaint and nonconformance rates and cycle times, and contributions to continuous improvement. The role may perform other duties as directed by supervision.

Requirements

Bachelor’s degree in engineering or a related field; a master’s degree may also be held.
At least 5 years of progressive engineering and/or technically focused experience; candidates who do not meet the education requirement may be considered with 10 or more years of relevant experience.
Strong technical and problem-solving foundation.
Good knowledge of Microsoft Office.
Solid technical aptitude and ability to contribute effectively to a team or produce technical results independently.
Competence in written and oral communication; candidates working 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 belief that failure is not an option.
Adherence to applicable quality, safety, environmental, security, FDA, company, and other regulatory requirements.

Nice To Haves

Training or certifications in problem-solving and project-management methodologies such as Six Sigma; Green Belt is a minimum preference and Black Belt is preferred.
Awareness of relevant domestic and international regulations and industry standards, such as ISO, QSR, UL, MDD, and TGA.
Master’s degree in engineering or a related field.

Responsibilities

Ensure internal and external customer expectations are met or exceeded and evaluate procedures that support production of quality products.
Apply engineering concepts to resolve acute or chronic problems and develop approaches to complex technical issues.
Conduct studies of process and measurement-system capability and provide technical guidance to management.
Develop documentation for process improvement and project implementation, and act independently on relevant technical matters.
Support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
Monitor assigned product manufacturing for compliance with Device Master Records, 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, assist with product transfers, and investigate product and process improvement opportunities using Integer methodologies.
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 non-conforming material dispositions follow procedures and corrective actions are adequate to prevent recurrence.
Lead and manage complaint investigations.
Participate in plant CAPA activities, including analysis of complaint, supplier quality, nonconforming material, training effectiveness, and root-cause data and trends.
Use data analysis and product and process observations to establish root causes of failures or justify improvements.
Support internal quality audit activities as applicable.
Assure adherence to the Quality Management System, support corrective and preventive action investigations and implementation, and contribute to quality KPIs and the journey to 5 Sigma.
Support site Hoshin plans, quality plans, validation master plans, quality improvement initiatives, and regular QA/RA metrics updates.
Ensure customer change notifications are initiated and completed as necessary, and support continuous improvement activities.
Support workplace organization and visual controls (5S), manufacturing standard work, training and certification programs, standardized problem solving, behavior-based safety, improvement ideas, and built-in-quality practices.
Support Integer Environmental, Health & Safety programs, meet defined goals and milestones, and generate and support implementation of continuous improvement suggestions.
Perform other duties as needed and as directed by the line of supervision.

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.