Quality Engineer

Description

The company has been in business for over 179 years and works as a pioneer in science. It serves Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology, with more than 42,000 employees worldwide and over 4,000 in the US and Canada.

This quality role supports quality assurance across operations. You will run assessments, review process efficiency and put best practices in place to find and fix quality problems, while working with cross-functional teams to keep quality aligned with company goals.

Responsibilities

• Manage day-to-day change management work: engineering change requests, engineering change orders, document change orders and prototype change orders.
• Review engineering and process documents and suggest changes with the right stakeholders before they enter the change workflow.
• Keep document revisions controlled and make sure documents reach the right people.
• Update document control records and documents to meet ISO 9001 QMS and ISO 14001 EMS standards.
• Audit quality logs and storage folders or databases for compliance and report what you find.
• Take part in VE, waiver, scrap, inspection and COPQ processes as business needs require.
• Support ISO 9001 QMS management, compliance work and audits.
• Build and track KPIs for document control, from analysis and approval through to implementation, with your reporting manager.
• Maintain master data, including item master and bills of materials, in the MRP database.
• Make changes to PDM or other document control databases in use.
• Help create documentation for new product introduction projects.
• Handle internal and external customer and supplier questions, including investigations, incoming part inspection, FAI parts, field returns and stock quality checks.
• Lead and support continuous improvement that fits business priorities.
• Assist or lead supplier quality, internal quality, customer quality, calibration and root cause analysis using CAPA, CAR and SCAR.
• Carry out projects the department manager assigns to meet departmental goals.
• Join or lead QMS and other quality ERP projects for System Landscape Modernization.
• Support the XRM facility in Dublin and subsidiary sites worldwide.

Requirements

• A degree in mechanical, electrical or mechatronics engineering.
• 5 years of work experience (preferred).
• Strong computer skills, especially MS Office including Excel and Outlook.
• Able to review mechanical and technical drawings and technical documents.
• Knowledge of instrument bill of materials (BOM) structures (preferred).
• Proficiency in SolidWorks for reviewing 2D and 3D CAD files (preferred).
• Able to learn new software and processes quickly.
• Knowledge of ISO 9001 QMS and ISO 14001 EMS (preferred).
• Able to run and lead investigations independently using CAPA methods such as 8D.
• Strong written and spoken communication and teamwork.
• Able to work on your own with limited guidance and contribute to a team.
• Able to adapt as demands change at a growing high-tech company and be available through the week as departmental and business needs require.
• Able to work across time zones with global stakeholders.

Conditions

The role is on-site.

Travel domestically and internationally, alone or in groups, to visit customers, suppliers and other company facilities as needed.

Annual pay range: $84,000 to $104,000.

Pay may depend on job location, scope, qualifications, education, experience, and how specialized or scarce the talent is.

The company provides equal employment opportunity regardless of race, color, religion, sex, gender, age, national origin, disability, military or veteran status, citizen status, sexual orientation, pregnancy, genetic predisposition, gender identity and any other characteristic protected by law.

Benefits

• Performance bonus or sales commissions may be available.
• Medical, vision and dental coverage.
• 401k matching and a retirement savings plan.
• Employee assistance programs.
• Vacation and sick pay.