Your Job
- To ensure all validation and quality control activities are compliant with the regulatory requirements, customer requirements, and internal QMS requirement in new product introduction phase.
- To ensure all products and process quality can meet specification.
- To ensure that the product sterilization process during manufacturing meets customer requirements.
- Act as core team member of a project during project launch phase.
What You Will Do
- Coordinate with customers to confirm the sterilization process, verify the protocol and report preparation and implementation, coordinate with suppliers to verify the sterilization process and perform daily control and issue handling, including subsequent re-validation and annual confirmation.
- Responsible for the development and validation of methods and equipment for biological load testing processes for corresponding products, as well as subsequent test data analysis, coordination with third-party testing, and internal testing training.
- Compilation and maintenance of SOPs for biological load testing methods and related equipment.
- Responsible for establishing and managing the pollution control process for the production and manufacturing process of corresponding products.
- Lead medical project process validation and verification and comply with global validation requirements. Create all the related new project validation protocol, reports and align with customer.
- Create all Quality plan/Inspection instruction for products and process, and perform the training to the responsible person.
- Change, nonconformance and deviation handling.
- Customer compliant handing, lead root cause analysis and implement
- improve action and prevent action, finish 8D or CAPA report and review
- with customer.
- Support plant continuous improvement/scrap reduction project.
- Other duties as assigned by supervisor.
Who You Are (Basic Qualifications)
- College degree and above.
- Knowledge in ISO13485 and QSR 820.
- 2 years working experience in medical device or pharmaceutical manufacturer.
- Sterilization process or have sterilization supplier management
- experience.
- Good communication skills, fluent English both in written and oral, strong
- problem-solving skills.
- Good analytic senses.
- Good computer skills, be familiar with EXCEL, WORD
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one ofthe world's largest privately held companies. Discover your potential to make a difference.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.