Senior Design Quality Engineer

SUMMARY:

The position of Senior Design Quality Engineer is responsible for developing, establishing, and maintaining risk management files for all new product development of orthopedic implants, instruments, and packaging. The Design Quality Engineer also participates in CAPA activities, quality initiatives, as well as postmarket engineering activities. WishBone Medical is a small start-up and this position will provide an opportunity to make a difference for the company long-term.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

• Facilitate risk management activities throughout all design phases
• Work with product development and design engineering in the completion of product verification and validation activities
• Work with product development, design, and supplier quality in definition of CTQs
• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Support development of US FDA submission requirements
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. May serve as coordinator in quality initiatives
• Support quality improvement projects for the site, including formal quality efforts such as CAPA, NCMR, and audit responses
• Perform complaint analysis and trending in support of post-market surveillance. Support post market and sustaining engineering efforts on commercialized product
• Support Health Hazard Evaluations (HHEs) to ensure risk assessment and root cause analysis are consistent across products and systems
• Comply with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Perform other related duties and responsibilities, as assigned

QUALIFICATION REQUIREMENTS:

• BS in Engineering or related science field
• 3-5 years' work experience in the medical device industry

OTHER SKILLS and ABILITIES:

• Experience with FDA requirements 21 CFR 820, knowledge of regulations such as GLP, GMP, ISO 13485 and ISO 14971, as well as other international regulatory requirements, preferred
• Experience in related areas, such as R&D or manufacturing, may also be applicable if experience includes work responsibilities listed above

Current Openings for Senior Design Quality Engineer Jobs at XXX DO NOT USE XXX WishBone Medical, Inc

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