Quality Engineer – ISO 9001 & Continuous Improvement

IDEX; West Henrietta (NY); On-site; USD 88,000 - 132,000; Full time

Benefits offered by this job

Health benefits

401(k) retirement savings with company

PTO

Job summary

IDEX Health & Science in the United States is seeking a Quality Engineer to ensure products meet specifications and regulatory requirements. You will own multiple quality domains, lead investigations, and collaborate with operations and engineering for process improvements.

The role requires strong problem-solving skills, experience with quality tools (FMEA, control plans, statistical methods), and the ability to travel up to 5%. On-site work predominates, with relocation considered.

Qualifications

• Bachelor’s degree in Engineering or equivalent combination of education and work experience.
• Minimum of 3–5 years Quality Engineering (preferred) or related engineering experience.
• Ability to lead teams to conduct investigations to determine root cause and develop, implement, and track the closure of corrective and preventative actions.
• Demonstrated experience with batch and component assembly processes, multi-tasking in a fast paced manufacturing environment and supporting cleanroom activities.
• Familiar with modern risk and quality tools such as FMEA, Control Plans, and Statistical techniques.
• Experience with ISO 9001 or similar ISO quality management system.
• Proficient with Microsoft Office (Word, Excel, Outlook, PowerPoint, Access) and Minitab.
• Familiarity with ERP/Document Control systems (e.g. Oracle, JDE, Adobe Acrobat, AutoCAD).
• Excellent written and oral communication skills
• Ability to travel up to 5% both domestic and international.

Responsibilities

• Lead, collaborate, facilitate, and support quality initiatives with ownership and integrity.
• Apply quality metrics, process mapping, Lean, VSM, Six Sigma, and CPIs to drive improvements.
• Take initiative and follow through to ensure organizational health.
• Interact with customers and suppliers on quality qualification, returns, and continuous improvement.
• Communicate updates to external parties and stakeholders.
• Be a positive team player and support the team to meet goals.
• Lead internal and supplier quality audits.
• Ensure compliance with ISO 9001 and company policies.
• Develop and implement quality planning, control plans, FMEA, inspection methodologies.
• Collaborate with Operations and Engineering to improve manufacturing and product quality/reliability.
• Develop KPI databases and countermeasures for continuous improvements.
• Participate in MRB activities and root-cause analysis.
• Drive 5S, Kaizen Lean methods, and other continuous improvement activities.

Skills

Quality engineering

FMEA

Control plans

Statistical methods

ISO 9001

Minitab

ERP systems

Communication skills

Travel flexibility

Education

Bachelor's degree in Engineering

Tools

Oracle

JDE

AutoCAD

Adobe Acrobat

Job description

IDEX Health & Science in the United States is seeking a Quality Engineer to ensure products meet specifications and regulatory requirements. You will own multiple quality domains, lead investigations, and collaborate with operations and engineering for process improvements.

The role requires strong problem-solving skills, experience with quality tools (FMEA, control plans, statistical methods), and the ability to travel up to 5%. On-site work predominates, with relocation considered.