Senior Quality Assurance Engineer
1 week ago
Job Title: Senior Quality Assurance Engineer
Company: MillenniumSoft
Key Responsibilities
- Facilitate and oversee design and process root cause analysis while addressing non-conforming products and complaint investigations.
- Demonstrate the capability to make and present decisions based on risk assessments.
- Prepare and deliver project updates and engage in technical discussions.
- Direct the development of risk assessments and testing methodologies.
- Oversee component qualifications, as well as design validation and verification processes.
- Lead investigations into product issues.
- Evaluate product modifications against original design specifications.
- Assist in translating design requirements into manufacturing control strategies.
- Provide assistance to the regulatory team in drafting technical submissions.
- Adhere to company policies and procedures, as well as governmental regulations.
Experience and Physical Requirements
The role requires the employee to regularly stand, walk, sit, utilize vision, and manipulate objects, tools, and office equipment. Frequent verbal communication with colleagues is essential. Occasional reaching, stooping, kneeling, or crouching may be necessary.
Skills and Qualifications
- Essential Qualifications:
Understanding of product usage and its impact on users to effectively manage risks. - Proficient in Quality Engineering methodologies (Sampling Plans, Root Cause Analysis, Statistics, etc.).
- Advanced knowledge of statistical and risk assessment techniques.
- Familiarity with test method development and validation, equipment qualifications, process and design validation, and component qualification methodologies.
- Strong interpersonal communication skills.
- Ability to analyze and enhance manufacturing and quality systems, including product design and prototyping.
- Proficient problem-solving skills.
- Effective oral and written communication abilities.
- Comprehension of regulatory standards, including ISO 13485 and ISO 14971.
Desirable Qualifications:
- Quality Engineering Certification (ASQ) or equivalent.
- Bachelor's degree in Engineering.
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