Job Listing
|
|
| Job ID: 14041000 |
|
| |
| Job Location: |
|
| |
|
|
| |
| How to Apply: | To see employer contact information, log in or register. |
| |
| Job Title: | Quality Engineer II |
| Work Type: | Work Days: Weekdays, Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular |
| |
| Salary Offered: | Unspecified |
| Benefits: | 401(k) or other retirement, Dental Insurance, Health Insurance, Holidays, Sick Leave or PTO, Vacation or PTO, Vision Plan |
| |
| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | |
| |
| Experience Required: | Unspecified |
| |
| Required Skills: | Requirements
Bachelor’s Degree in engineering or related discipline
3 years of Quality Engineering experience in catheter medical device manufacturing
3 years of experience in support of QMS audits
Experience working in quality systems defined in 21 CFR 820 and ISO 13485
Demonstrated ability to implement, execute, and maintain quality system policies and procedures
Ability to define problems, collect data, establish facts, and draw valid conclusions
Diverse knowledge of inspection and control methods, techniques, and documentation
Ability to interpret and understand drawing specifications, tolerances, procedures for inspection, and the application of sampling plans
Able to sit/stand at a desk for extended periods of time |
| Preferred Skills: | Preferred Skills & Experience
2 years’ experience working with automated inspection systems
Demonstrated experience in software validation
Experience in product development and process design development team environment |
| |
| |
| |
|
| Job Description: |
Join VitalPath in New Hope as a Quality Engineer II!
About VitalPath
VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!
About the Position
This person is primarily responsible for providing technical support to ensure Customer requirements are understood and properly implemented. The Quality Engineer II will work cross-functionally contributing to Development and Manufacturing, Engineering, Qualification, and Validation activities. Supports Engineering, Operations, Sales, and Quality by providing effective Non-conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities.
Responsibilities
Support engineering, manufacturing, inspection, qualification, and validation of products
Develop and implement quality improvement with working knowledge of Quality standards and systems
Assures compliance of the Quality Management Systems (QMS), ISO 13485:2016, and customer/regulatory requirements
Support Development activities for the transition of Manufacturing Processes and related controlled documentation from prototype control to pre-production control to commercial production control
Works with customers and suppliers to resolve quality related issues
Support and participate in 3rd party and customer audits, as needed
Work cross-functionally on failure investigations, root-cause analysis, and corrective action implementation
Develop, approve, review, and update controlled documents such as procedures, manufacturing procedures, work instructions, forms, etc.
Train personnel, as needed, on new or updated QMS documents
Review and approve customer and internal drawings and specifications
Ensure that records are established, accurate and maintained per QMD requirements
Develop and implement systems for Quality and Inspection support
Support implementation of overall company systems that related to Quality
Other duties as assigned
Refer to ID when applying |
|