Your Job
The main focus of the role is primarily to ensure the quality standards are met. In this role you will form part of a cross functional team involved in the day to day activities and other QMS activities as needed. You will be working in both manufacturing & non-manufacturing (QMS process based) setting. You will also have some supervisory responsibility, including completing probation and annual performance reviews and providing direct coaching, guidance and support
Our Team
Reporting to the Site Quality Lead you will be part of a highly motivated team of 4 engineers within the Quality department.
What You Will Do
- Be part of a cross functional team involved in the day to day QMS activities.
- Support the investigation, root cause, corrective action in relation to all non conformities and CAPA activities.
- Work closely with Production in relation to new day to day quality issues.
- Perform and provide support to validations, metrology, document control, change control and auditing as required.
- Interact directly with vendors and customers.
- Be part of improvement activities.
- Promote a positive environment where achievements and accountabilities are acknowledged and open two-way communication encouraged
- Provide input from a quality perspective to product & process risk assessments, pFMEA.
- Set up/amendment to routines and inspection plans in SAP.
- Liaise with other departments as required as part of day-to-day activities.
Who You Are (Basic Qualifications)
Requirements:
- Bachelor's degree or equivalent in Quality, Engineering, Science or related discipline
- Good working knowledge of ISO 13485
- Past working experience, preferably in a medical device or manufacturing environment
- Excellent attention to detail in verbal & written communication, with a proven technical protocol & report writing background
- MS Office proficient
What Will Put You Ahead
- FDA experience would be preferred, but not essential
- Eperience with SAP will be beneficial.
- Previous experience in a medical device setting.
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
As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
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.
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