职位描述

Your key responsibilities

• Actively participate on custom design teams to support custom implant manufacturing.
• Lead the risk management process for the site as required.
• Participate in the development and improvement of the manufacturing processes for existing and new products. 
• Work closely with key stakeholders to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, 4D, etc). 
• Review/approve product and process change control documentation and specifications on a divisional level as a reviewer of change control requests.
• Provide technical expertise and support to the business
• Review and approve regulatory standard change impact assessments.
• Support product transfers to other plants/facilities when necessary. 
• Review/approve nonconforming material and system documentation.
• Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of the business
• Achievement of strategic goals and annual operating budgets
• Create and/or maintain SOPs, WI, and Quality forms.
• Perform other duties as defined by QE management.

What are we looking for?

• BS or equivalent in engineering.
• A minimum of 1-3 years related experience in in the medical device or pharmaceutical industry
• Working knowledge of regulatory requirements:  ISO 13485, Quality System Regulation and Medical Device Directive.
• Working knowledge and application of quality tools such as FMEA, SPC/Process Control, Root Cause Analysis. 
• Analytical and methodical approach to problem solving with effective communication skills at all organizational levels.
• Ability to work with cross functional teams
• Ability to plan and conduct meetings
• Plan, organize, and implement multiple concurrent tasks and projects
• Ability to negotiate internally and externally with FDA, NB and other regulatory bodies
• Excellent analytical and writing skills
• Effective organizational skills