International manufacturing organization
Opportunity to work with an excellent team
About Our Client
Market leading, medical device manufacturing organization.
- Work with customers on customer complaints (Provide them with Containment action, Root cause analysis and short / long term Corrective and Preventive actions)
- Perform training for manufacturing / Quality associates to work instructions and procedures
- Help customers with Supplied Data Agreement requests
- Analyze and disposition Non-Conformance Reports
- Responsible for contacting customers with any deviation from specification
- Identification of adverse quality trends or conditions
- Initiate corrective and preventive actions
- Monitor and track Data collection and Analysis
- Support engineering with process validations (IQ, OQ, PQ)
- Work with Engineering to complete PPAP documentation (PFMEA, Control Plan, Flow Chart and Part Submission Warrant).
- Create, review and update Procedures and Work Instructions
- Perform Internal and supplier audits
- Initiate Engineering Change requests to implement any change in documentation
- Support Quality control inspectors with gaging techniques
- Develop and implement various quality practices designed to track performance indices
- Publish performance indices at regular intervals
- Discuss trends and make recommendations with direct managers
- Self-starter and the ability to work with minimal supervision
The Successful Applicant
- BS Degree in Engineering or educational equivalent plus at least two years of related experience.
- The candidate must also be computer literate with proficiency in MS PowerPoint, Excel, Word and Minitab or other equivalent statistical analysis software.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- CQE or a CQA Certification is a plus.
- Work within an ISO 13485 regulated environment
- Ability to design and develop quality inspection tooling
What's on Offer
Excellent compensation package