What are the responsibilities and job description for the Senior Quality Engineer position at Medical Device Manufacture?
Responsibilities:
- Manage all quality-related issues within the manufacturing team (e.g. internal, supplier, customer and customer warranty).
- Identify root cause and instigate permanent corrective actions for product quality issues.
- Ensure compliance and assist with adherence to the Quality Management system.
- Assist with training of quality awareness.
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or components.
- Develops and initiates standards and methods for inspection, testing and evaluation on sub-system and system integration.
- Devises sampling procedures and designs and develops control plans and instructions for recording, evaluating and reporting quality.
- Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.
- Compiles and writes training material and conducts training sessions on quality control and assurance activities.
- Supports Manufacturing Engineers and Program Managers with customer interfaces as necessary on quality related issues.
- Assist with developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
- Provides liaison to various regulatory bodies.
- Analyses reports and returned products and recommends corrective action.
- Other duties as assigned by management.
Job Requirements:
- 10 years of experience in Quality Engineer or equivalent.
- 5 years of experience in electro-mechanical manufacturing environment.
- Minimum a Bachelor degree in science or engineering.
- Communication skills.
- Knowledge of the organization’s product.
- Attention to detail.
- Analysis, critical thinking and problem-solving skills.
- Interpersonal skills.
- Ability to handle stress.
- Hands-on experience with Quality Management Systems (QMS) and testing methodologies.
- In-depth understanding of technical documentation.
- Familiarity with statistical analysis.
- Great attention to detail and problem-solving abilities.
Salary : $70,000 - $90,000