Quality - Quality Engineer

Viant Medical - Vega Baja, PR

Full-time - Entry Level

Vega Baja, PR

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

The Quality Engineer develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet internal, customer, and regulatory requirements. Serves as a Quality representative for quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide focused quality engineering support in a project-based role for site, divisional or global projects.

Responsibilities

• Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Complies and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• Ensures that corrective measures meet acceptable reliability standards.
• Analyzes preliminary plans and develops reliability-engineering programs to achieve company, customer and governmental agency reliability objectives.
• May develop mathematical models to identify units, batches or processes posing excessive failure risks.
• Proposes changes in design or formulation to improve system and/or process reliability.
• Utilizes standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Leads corrective and preventive action (CAPA) projects using root cause analysis as well as identifying and implementing robust solutions.
• Must comply with regulatory requirements, and company Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
• Reviews and approves product, process, software qualification and validation and other change control related documentation.
• Plans, organizes and prioritizes own daily work routine to meet established schedule and production support.
• Leads and supports continuous improvement activities for product processes and quality systems.

Requirements

• Bachelor's degree in Engineering-related discipline.
• 1-4 years in medical device or equivalent.
• Demonstrated interpersonal skills with ability to work within a team environment.
• Training experience to FDA 21CFR820, 21CFR Part4, 21CFR Part11 regulations and ISO 13485 standards.
• Strong written/verbal communication skills.

Nice-to-haves

• Six Sigma problem-solving methodologies.