Sr Design Quality Engineer – Hardware

Sr Design Quality Engineer – Hardware

Requirements

• Requires a minimum of a BS degree in science, engineering, or relevant subject area
• Minimum 3 years’ experience with emphasis on R&D development, Quality Engineering and Design Control
• Proficient in Microsoft Office suite (Excel, Word, PowerPoint)
• Excellent verbal and written communication skills
• Ability to work independently as well as part of a team
• Ability to use root cause analysis tools and execute corrective action plans
• Knowledge of quality systems and regulatory standards requirements including 21CFR 820, ISO13485, ISO14971
• Familiarity with GMP and regulatory requirements for medical devices

Responsibilities

• Responsible for being the core team quality representative for design control projects – new product development as well as sustaining efforts
• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support
• Provide clarification and guidance to teams on overall quality system with emphasis in design controls
• Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release
• Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation
• Active participant in the development of product requirement, product system hazard analysis and design reviews
• Lead/own or support CAPA investigations and CAPA closures
• Ensure product technical files and Design History Files are complete and auditable
• Follow Quality System Regulations and established procedures
• Responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints
• Proactively engage partners to drive consensus and resolve issues in a timely fashion
• Provide statistical support and expertise and analytical problem solving for product development and manufacturing

Preferred Qualifications

• Previous experience in quality engineering role in medical device industry preferred
• Experience in production and process control is preferred
• Quality Engineering Certification (ASQ) or equivalent is preferred