Client is looking for a quality engineer to perform a variety of functions within the PHP QA department, including a resource for Focus Factory and support the Quality system. Promotes and maintains all company policies. Complies with the facility safety program and reports any unsafe conditions to management. Essential Functions:
1. Supports and promotes all company policies. Supports and promotes the company Safety Policies
2. Supports and maintains the quality system
3. Serves as a Quality Assurance resource to assigned departmental functions.
4. Reports to management on quality concerns
5. Participates and/or develops product and process validations
6. Participates and/or develops new material qualifications.
7. Participate in New Product Development to assure quality considerations are adequately cover in the design, testing and release of materials, components, and products.
8. Analyzes causes of defects and participates in recommendation of corrective actions
9. Participates in the designing of methods for evaluating product quality; establishes test programs to evaluate materials, processes and products.
10. Prepares inspection instructions, systems and procedures
11. Initiates actions to dispose of nonconforming product.
12. Participates in new supplier qualifications including supplier change requests and PPAP (purchase part approval processes) evaluations
13. Other duties as assigned by supervision.
- Practical knowledge of FDA QSR 820, ISO 13485 and plastics injection molding technology
- Excellent interpersonal skills at all levels of the organization
- Basic knowledge of statistical methods
- Excellent communication skills, both written and oral.
- Excellent problem-solving skills
- Good computer skills (Microsoft Office)
- ASQ CQA
- CQIT certification preferred
Any specific industry experience
Experience: 2-4 year minimum Quality Assurance or other direct experience in a manufacturing environment - experience in a medical device, pharmaceutical or aerospace industry required
Education required/preferred: 4 year Bachelor's degree