Senior Quality Engineer

• Prioritizes, supports, and facilitates the workload to other Quality Engineers, Asc. Quality Engineers, and Quality Engineering technicians within their Value Stream or Work Stream.
• Measures Performance and objectives and drives continuous improvement through PDCA(A3), CAPA, and Six Sigma.
• Leads and/or supports large-scale projects to support value streams, or introduce new products.
• Review design transfer activities to ensure that all deliverables have been met prior to release.
• Reviews and Authorizes Engineering Change Orders, Manufacturing Change Orders, Source of Supply, Control Plans, PFMEA’s, SOP, and Procedure change requests
• Review nonconformance investigations and corrective actions.
• Develops team members by training them in Quality Sciences, Problem Solving/Six Sigma (PDCA), cGMP, and other technical requirements.
• Reviews and approves Quality Plans, Validation Protocols, Test Reports, Engineering Studies, and TMV’s. 
• Perform internal and supplier audits 
• Disposition, perform containment, and evaluate the risk of nonconforming material
• Identify root cause and corrective action by supporting the CAPA process.
• Work with manufacturing engineers to implement risk analysis, manufacturing control plans, and inspection plans for in-process and final inspection.  
• Work with manufacturing engineers to evaluate process risk through supporting PFMEA activities
• Support Quality and Manufacturing Engineering to write and Execute Test Method Validation protocols and reports.
• Create and/or execute Quality Plans.
• Create and/or execute Engineering studies, Protocols and Test reports.
• Coordination with the Quality Control department to resolve general concerns.
• Support Inspections and Audits
• Support and evaluate process changes for qualification.
• Create and updates SOP’s, WI, and forms as required.
• Supports process development with design transfer activities.
• Supports FDA and ISO 13485 inspections/audits.
• Creates and updates SOP’s, WI, and forms as required
• Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action.   
• Designs and procures production gaging when appropriate.
• Evaluate and qualify manufacturing processes to ensure technical requirements can be met. (MSA, Cpk, assembly validation, etc)  Provide process development and operations with inspection criteria prior to manufacturing.
• Manage process validations and process improvements
• Planning, execution, and responding to QMS documents and problem resolutions
• Manage corrective actions, rework plans, deviations, and non-conformances.  Issues corrective actions and drives root cause investigation and corrective action implementation.  Sr. QE is responsible for timely resolution of discrepant materials.
• Assist CAPA program with analysis and efforts relative to product quality issues. Identify and trend quality issues. Support analysis of CAPA Program data and identify/trend quality issues.
• Planning, execution and ensuring department goals and objectives are met
• Train, guide, influence and mentor Jr. or new Quality Engineers
• Participate in resource planning, recruiting, and budgeting.  Attend project meetings and establish activity timelines to meet department and company Goals and Objectives.
• Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, 21 CFR 820, and the European Medical Device Regulation.

Basic Qualifications

• Five years minimum experience in a regulated manufacturing environment in Quality Engineering and / or Manufacturing Engineering required (21 CFR 820, ISO 13485).

Preferred Qualifications:

• Expertise in interpreting and applying GD&T. 
• Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet.
• Experience in electronic QMS and ERP systems
• Strong mathematical skills, including statistics. (Tolerance analysis, significance tests, process capability, sampling plans, GD&T).
• American Society for Quality Certified Engineer (CQE)
• Strong understand of ISO 13485, CFR 21 820, and MDR.
• Strong manufacturing processes expertise. 
• Clean room experience.
• Proficiency in Project Management
• Proficiency in Lean Manufacturing. 
• Strong Validation Experience.

• Requires a bachelor’s degree or comparable experience in a business, science, technical, or engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME) or equivalent experience. 
• Five years minimum experience in a regulated manufacturing environment in Quality Engineering and / or Manufacturing Engineering required (21 CFR 820, ISO 13485).

10% travel

20/20 vision with or without corrective lenses

Ability to lift 25 pounds