We are recruiting for an Operations Director to join an SME Medical Device manufacturer. The role is responsible for all aspects of the company's Operations function including Production, Quality Control, Engineering and Facilities whilst adhering to Medical Device Quality and Regulatory standards. The role reports directly to the MD and is part of the Management Board.
Responsibilities;
- Responsible for activities as defined in ISO13485.
- Attend Quality Management Review.
- Manage Health Safety and Environmental related activities.
- Lead focus on investigation and resolution of assigned Operations related CAPA's.
- Champion compliance to relevant medical device standards through ensuring that all Operations activities are performed in accordance with issued procedures and that any non-compliant activities are fully resolved or highlighted to the Managing Director and Director of QA/RA
Key skills / abilities
- Demonstrable extensive experience in managing multi-functional Operations teams in medical device or closely related industry.
- Highly experienced in lean manufacturing and process improvements.
- Strong project management skills with relevant experience, ability to make data driven decisions and strategically plan and execute this.
- Experience with inventory management.
- Able to implement technology to support production and data generation.
- Can optimise workflow and be customer centric.
- Significant experience of safety systems and legislation.
- Understanding of relevant Medical Device regulations.
- Experience of operating to GMP standards.
- Demonstrate proficiency in budget preparation, manufacturing standard costs, manufacturing ratios and profitability optimisation.
- Able to get on with and influence people both internally and externally to achieve objectives.
- Ability to take the lead and ownership of all operational aspects with minimal supervision.
- Must be a team player and able to motivate others around them.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
