An exciting opportunity has arisen to join a dynamic, independent developer and manufacturer of innovative and technologically advanced products for the global surgical and advanced wound care markets.
Our products, manufactured out of two sites in the UK, are sold in more than 70 countries via a network of multinational or regional partners and distributors, as well as via our own direct sales forces in the U.K., Germany, the Czech Republic and Russia. Established in 1991, we employ over 500 employees.
To support continued business growth, we are now looking to recruit a Senior Quality Manager (UK ) to join the Winsford Quality Team. The main purpose of the role is to set up clear quality objectives and goals for UK sites in line with Group Quality strategy and company business plan. This role will report to the QA /RA Director.
Salary : Highly competitive basic salary, bonus scheme, generous contributory company pension, life assurance and an exciting benefits package including cycle to work scheme, holiday purchase scheme, healthcare.
- This position has full responsibility in quality management for UK sites
- To maintain and improve quality management system to comply with the requirements of MDD 94/42/EEC and relevant GMP, ISO13485 and FDA 21 CFR 820
- To ensure quality team are well trained and motivated in doing work
- To ensure that effective systems are implemented and maintained in ensuring adequate control of all raw materials and bought-in goods, work in progress and manufactured product
- As part of site management team, establish and manage quality improvement projects in accordance with company objectives
- To ensure sufficient support to new product development
- Transposition of applicable national/international standards into quality system procedures and implement them across UK sites
- Plan and budget quality resource
- Quality System Management Representative for UK sites
Knowledge and skills:
- Educated to degree level or above on science, engineering or material
- Good experience in similar role with tracking record in medical device manufacturing environment. Working knowledge of ISO9001/ISO13485/MDD 93/42/EEC or equivalent
- Demonstrate excellent leadership in previous roles
- Experience in continues improvement and knowledge on six-sigma tools is preferable
- Experience on staff management is essential
- Clear understanding and good experience on design control process
- Experience on competent authority inspection such as FDA, TGA inspection is preferable
- Experience on electronic quality management system is preferable
- Excellent written and verbal communication skills
- Good PC skills