• Any Local site or S+N Shared Quality System / Health, Safety & Environment Policy, Procedure or Work Instruction contained in the individual’s training plans.

• Applicable standards as defined in the Quality Manual (including but not limited to)

• ISO 9001
• ISO 14001
• ISO 13485
• Applicable regulations as defined in the Quality Manual (including but not limited to)

• EU Medical Device Directive / Regulation

• Regulations issued by the 5 MDSAP Jurisdictions

• UK Human Medicines & Medical Device Regulations

• c GMP, c GDP (including 2013/C 343/01), c GLP as applicable for each role

• Work within cross functional teams in order to identify opportunities for Cost Saving Initiatives.
• Has basic knowledge of products and processes acts with initiative to grow their knowledge base.
• Champions Ideas Unlimited and direct others to the Pipeline Process in order to ensure Opportunities are captured for evaluation.
• Has sufficient understanding to use their knowledge to develop concepts.
• Undertakes research and development activities to confirm feasibility of ideas ahead of business case generation.
• Makes recommendations on if concepts and ideas should be progressed or made inactive.

• Execute, with support and guidance, projects according to the project governance framework and follow any reporting requirements. (10%)
• Undertake routine activities, with some guidance from senior team members, such as technical or engineering trials within the framework of the technical study system and other appropriate internal procedures. (30%)
• Gather and analyse large amounts of data in order to support the development of comprehensive business cases. (20%)
• Make sure data is robust and accurate to ensure integrity is maintained, product safety and efficacy is not adversely affected, and Quality standards are not compromised. (20%)
• Will act as a change control leader on simple projects, may act as a change leader on complex projects with the support of senior members of the team. (20%)

• Understands other functions and their roles within the S+N business.
• S+N业务中的其他职能及其角色
• Confidently present information to a cross functional audience.
• Asks questions and seeks clarification in order to deliver the best outcomes for S+N.
• S+N实现最佳输出。
• Acts with integrity at all times, putting the needs of S+N and its customers at the fore of all recommendations.
• S+N及其客户的需求置于所有建议的首位。
• Act as a role model and mentor to more junior members of the team.

• 2年的工作经验
• 或者

• 4年的科学、技术、工程或高级生产岗位工作经验