Advanced Quality Engineer - Oral Care

Description Overview

This person is responsible for identifying and mitigating regulatory, product, and business risks during new product development at the supplier and own 3rd party product tests failures investigations and CAPAs. Additionally, this person is also expected to understand medical device risk management processes/standards, APQP tools (e.g. PPAP production Part Approval process, Supplier Initiated Change requests, process validations. qualifications of process/test method, Supplier corrective action Requests) and demonstrate appropriate use of these tools in the course of their work.
 

Scope of the Role

• Enforce adherence to regulatory requirements and standards during Project Planning, Project execution and Project delivery  
• Provide advanced new product development support as part of a cross-departmental project team, including risk management documentation review, specification evaluation, and compliance with quality system processes at the supplier. Provide guidance on DFMEA, PFMEA, Human error prevention, Risk Management files, V&V, Design Transfer, DHF, DMR creation
• Write and review supplier process validation protocols, recognizing opportunities for risk and appropriately challenging the process for those risks as part of the process validation strategy.
• Oversight of process validation protocol execution; writing or reviewing the post-execution report and proper handling any deviations during execution. Work with R&D, Suppliers, and Engineering to determine the proper deviation resolution based on the risk
• Understanding product lines and be able to perform technical problem solving for responding to 3rd party failures. Execute investigations of externally sourced nonconforming material. Including root Owning CAPAs. Recognize opportunities to expand corrective actions across similar processes and work to implement.
• Use advanced root cause analysis to address issues during product development, production, and post-market surveillance activities, including brainstorming, 5-whys, and fishbone diagrams. Lead cross-departmental teams on root cause analysis.
• Ensure effective change control using thorough change evaluation and use of supporting documentation
• Support external regulatory inspections / audits for Supplier related process/product quality
• Responsible for keeping current with, maintaining, reviewing and implementing applicable regulations and standards
• Other duties as assigned by Manager

Experience Required

• BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science
• Two years of experience in the medical device, cosmetic or pharmaceutical industry, desired- injection molding experience
• Working knowledge of applicable regulations and standards for medical device industry
• Working knowledge of ISO14971, ISO13485, ISO22716 standards
• Ability to identify and use statistically-valid sampling plans 
• Works independently to achieve goals, using knowledge and experience to solve problems
• Demonstrated ability to work with and manage suppliers 
• Basic project management skills, including the ability to track action items, owners, and due dates and communicate clearly to personnel and management
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
• Ability to use creative reasoning and logic to address novel situations and fulfill regulatory and customer requirements
• Strong verbal and written communication skills in English, with demonstrated ability to successfully work with peer group and frontline organization
• Proficiency with Minitab, PC skills such as Word, Excel, PowerPoint, and Minitab software with the ability to quickly learn various in-house software applications
• Able to work independently to deliver on multiple objectives and goals according to business commitments
• Available to travel as needed to visit other company or partner locations
• Eligible to work in the United States without corporate sponsorship now and within the future