Job Details

Job DescriptionJob DescriptionDescriptionThe Senior Engineer Quality Operation shall provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.
Key Responsibilities

• Develop and validate statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes, and components.
• Analyze, justify, recommend and qualify purchasing of in house or vendor supplied inspection equipment.
• Drive disposition non-conforming (NC) product within MRB, coordinating related containment and investigation actions for timely NC closure.
• Responsible for organizing, assisting with, and documenting Stock Audits for potentially nonconforming product.
• Initiate and provide support for distributed product risk assessments and health hazard evaluations. Provide information and records to management regarding potential field actions.
• Communicate & collaborate with suppliers regarding NC, escalating supplier corrective action requests as required.
• Support manufacturing transfer between sites/facilities/suppliers, executing appropriate quality activities.
• Performs critical assessment of internal and supplier proposed change management activities.
• Identifies and implements quality system improvements.
• Maintain Key Performance Indicators (KPIs) for monitoring of process, quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Understanding of risk management practices and concepts and applying knowledge to operation.
• Leads and/or participates in Root Cause Analysis and Corrective and Preventive Actions.
• Engage in development and improvement of internal manufacturing processes for existing products.
• Drive continuous improvement actions to reduce defects and improve process performance.
• Provide leadership and subject matter expertise in Quality Assurance activities to the overall sites, including but not limited to risk management, process validation, software validation, quality control, design control, statistical methodology, quality inspection sampling plan.
• Direct or assist inspection training for QC inspectors or QA technicians.
• Perform process audits and lead GEMBA walks in support of compliance and continuous improvement.
• Assist and support cross functional team members as necessary.
• Knows and apply the Quality System and any appropriate Federal and International standards.

Skills Knowledge and ExpertiseEducation:

• Bachelor's Degree in a science, engineering or related discipline from an accredited institution required; Master's Degree

Experience:

• Minimum 7 years' experience or equivalent in highly regulated industry, medical device experience
• Experience in GD&T and use of advanced inspection equipment
• Experience in interaction with regulatory agencies (FDA, BSI, etc.) desired
• Advanced level of technical software proficiency
• Advanced Quality Systems knowledge required

Functional/Technical Knowledge, Skills and Abilities Required:

• ASQ Certified Quality Engineer or equivalent, ASQ Six Sigma Black Belt
• Understanding of US and International Medical Device Regulations
• Familiarity with ISO 13485 and ISO 14971 required
• Strong knowledge of Quality body of knowledge (e.g. Risk Management, CAPA, Audits, Statistics).
• Ability to work effectively in a team environment