Manager, Quality Engineering

Manager, Quality Engineering

The Quality Engineering Manager is responsible for the development, application, validation and maintenance of manufacturing and quality management systems associated with compliance to internal procedures, customer requirements and applicable regulatory standards for products and components.

What you will do :

• Performs and documents timely Corrective and Preventive Actions (CAPA) investigations.
• Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation.
• Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines.
• Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regard to non-conformances, supplier changes, etc.
• Performs product support for product development and commercial products (reviews / approves product specifications, customer drawings, product validations protocols).
• Performs statistical data analysis utilizing statistical software (Minitab and Excel).
• Develops and implements statistical methods and designs experiments to support process control and process / product improvement.
• Performs physical and visual Test Method Validation / Gage R & R activities by developing and executing protocols for new or existing processes.
• Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.).
• Supports development and implementation of methods for sampling, inspection, testing and evaluation of products.
• Interfaces with customers to provide technical support for our products / complaints / change control.
• Reviews / approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.)
• Supports customer and / or third-party audits as required.
• May be trained as an auditor and perform quality audits.
• Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.
• Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement.
• Completes performance appraisals and reviews with employees; recommends salary increases to management and HR.
• Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements.
• Manages other Quality Engineers, to be able to participate in their development and performance reviews.
• Supports Strategic accounts as assigned and as needed

Who you are :

What we offer :

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws.