Sr Design Quality Engineer; Mechanical​/Electrical

Provides design quality engineering guidance and support for New Product Introduction (NPI) and/or Product Life Cycle Management (LCM) activities with a focus on product quality while ensuring compliance to company-wide Quality Management System and regulatory requirements for life science products. Provides specific quality engineering support to Risk Management, Quality improvements, Design Verification and Validation, and Design Control processes. Applies in-depth knowledge of quality engineering principals, relevant regulations, standards, industry best practices, and other related disciplines to assignments.

Independently plans and executes complex projects and assignments within broad guidelines, exercising judgment based on analysis of multiple sources of information. Receives minimal guidance and acts as a resource for colleagues with less experience.

• Owns the Risk Management process, collaborating with representatives from other functional areas to facilitate risk analyses and design control processes, reviewing and approving design verification and validation documentation.
• Performs complex technical investigations including formal NCs and CAPAs coordinating cross-functionally to ensure sound experimental design, effective analysis of multiple sources of information, appropriate risk analysis, design control, and verification and validation, and timely investigation closure.
• Acts as a resource for colleagues in risk management, design control, verification and validation, or CAPA and supports new product introduction, design changes, and post-launch activities.
• Provides training and informal guidance on quality management system elements to colleagues with less experience and representatives from other functional areas.
• Uses best practices and knowledge of internal and external business issues to identify and recommend improvements to quality systems, products, and processes in alignment with quality and business objectives.
• Supports and participates in cross-functional projects and may lead small projects with manageable risks and resource requirements.
• Contributes technical improvements that enhance quality systems and support business goals. Applies appropriate tools and methods (e.g. 6-Sigma, Lean, Statistical methodologies) to improve products, processes, and services.
• Participates in technical reviews, explains difficult or sensitive quality information, and works to build cross-functional consensus.
• Ensures quality control plans are commensurate with product risk and consistently followed across own and related teams.
• Communicates business-related issues and opportunities to the next management level and recommends appropriate actions within the role's scope.
• Supports internal, external, and third-party audits as Quality Subject Matter Expert and responds to observations in support of compliance with quality management system elements.
• Provides back-room support for third-party inspections and audits, such as Registrar, Notified Body, FDA, or customer audits.
• May interface during audits with regulatory agencies or customers.
• May interface with contract laboratories on behalf of ASP and works to build consensus on technical and quality requirements.

• Bachelor’s Degree in Engineering, Science, or other technical field. Engineering degree preferred
• At least 4 years of experience in Quality Assurance, Quality Engineering, or related field.
• Minimum 3 years quality engineering experience in FDA or other regulated industry (medical device, pharmaceutical, aerospace, etc.) or equivalent.

• Outstanding business and technical communication skills (verbal, written, presentation).
• Experience planning and…