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Senior Quality Assurance Engineer
2 months ago
Job Title: Senior Quality Assurance Engineer
Company: MillenniumSoft
Key Responsibilities
- Facilitate and oversee design and process root cause analysis while managing non-conforming product and complaint investigations.
- Demonstrate the ability to make informed, risk-based decisions and effectively communicate them.
- Prepare and deliver project updates and engage in technical discussions with stakeholders.
- Direct the development of risk assessments and testing methodologies.
- Oversee component qualifications, as well as design validation and verification processes.
- Lead investigations related to product quality and compliance.
- Evaluate product modifications in relation to original design specifications.
- Assist in translating design requirements into manufacturing control plans.
- Provide assistance to the regulatory team in drafting technical submissions.
- Adhere to company protocols, policies, and applicable regulations.
Experience and Qualifications
Physical Requirements:
The role requires the employee to regularly stand, walk, sit, utilize visual acuity, and manipulate objects, tools, and office equipment. Frequent verbal communication with colleagues is necessary. Occasional reaching, stooping, kneeling, or crouching may be required.
Essential Skills & Certifications
- Required Qualifications:
Comprehensive understanding of product usage and its impact on users to effectively manage associated risks. - Proficient in Quality Engineering methodologies (Sampling Plans, Root Cause Analysis, Statistical Analysis, 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.
- Excellent interpersonal and communication skills.
- Ability to analyze and enhance manufacturing and quality systems, including product design and prototyping.
- Strong problem-solving capabilities.
- Effective oral and written presentation skills.
- Understanding of regulatory standards, including ISO 13485 and ISO 14971.
Preferred Qualifications:
- Quality Engineering Certification (ASQ) or equivalent.
- Bachelor's degree in Engineering.
