QA/R&D co-ordinator
Are you passionate about making life better for patients worldwide?
If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home. We are looking for people who want to improve outcomes for healthcare professionals and their patients.
We are recruiting for an experienced QA/R&D co-ordinator based in Changshu, China.
As the owner of QA and laboratory activities for the CNB factory, lead and support the development and implementation of new products and/or improved materials, and drive manufacturing changes for existing products to meet customer needs.
KEY ACCOUNTABILITIES
• Plan, lead and document Quality process activities in within the local QMS.
• Define the scope of product and process validation, prepare validation plans, and compile Process Validation Summary Reports..
• Manage the risk management process, ensuring risk-based validations for processes in change projects.
• Ensure successful design transfer activities.
• Drive and execute manufacturing projects with limited complexity and business impact.
• Deliver assigned design control responsibilities for development and change projects in accordance with the local QMS.
• Provide support to manufacturing in resolving process and material-related issues.
KEY DECISIONS
• Make decisions in line with appointed roles in design and change projects (e.g., Change Lead, Manufacturing Owner, Material Component Owner, Validation Responsible)
KEY REQUIREMENTS
Capabilities
• Good knowledge of technology management and industrialization of medical devices.
• In depth understanding of process validation in medical industry.
• Solid knowledge of Design and Change Control
• English, good level
• Knowledge of Regulatory Requirements and standards related to medical devices.
Qualifications and Experience
• Academic background in engineering (Bachelor’s or Master’s degree) in mechanical, material, chemical engineering or equivalent.
Min 5 years of experience in a regulated industry, preferably medical devices.
ABOUT MOLNLYCKE
Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.
We specialise in:
Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients.
Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves.
Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.