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