Quality Engineer

SUMMARY

Develops and implements quality control systems, inspects and tests products, and analyzes data to ensure products meet safety and quality standards such as ISO13485, Medical Device Regulation 2017/745 (EU MDR), 93/42/EEC, MSDAP and the US Code of Federal Regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities include the following. Other duties may be assigned.

• Review and Analysis Review and analyze requirements, specifications, and design documents to ensure full test coverage for lot release
• Test Planning Create comprehensive test planning documents for existing and new products
• Automation Develop and implement performance criteria for testing equipment and in process testing to meet specification requirements
• Defect Management Identify and document defects and evaluate improvements for changes to improve compliance with specifications and standards
• Documentation Maintain detailed records of all testing including defects
• CAPA Utilize the Quality System to ensure CAPA system is successful and compliant
• Document Control Responsible for Document Control of existing procedures and records, ensuring compliance with all applicable Standards and Requirements
• Auditing Internal and supplier audit training for EUMDR and ISO 13485
• Lot Release Review and ensure compliance in releasing and verifying DHR Lot release
• Data Analysis: Use statistical analysis and various software to analyze complex data and make data-driven decisions
• Provides QA support during third party audits
• Identifies deadlines and implements methods to comply with responsibilities in a timely fashion
• Ability to get along with others, follows directions, and works well under stressful conditions
• Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.

SUPERVISORY RESPONSIBILITIES

None

EDUCATION and/or EXPERIENCE

Bachelor’s degree required. 2 – 5 years’ related work experience. Medical device experience and customer service experience required. Six Sigma black belt, preferred. Must understand and know how to navigate a CAPA through the Quality System. Working knowledge of ISO 13485, 21 CFR Part 820.100. Experience in computer/database applications, proficiency in Microsoft Outlook, Word, and Excel.

INTELLECTUAL SKILLS

The intellectual skills described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to speak, read and write English, bilingual in Spanish a plus.
• Ability to work with minimal supervision.
• Ability to be proactive, take initiative to be productive and recognize and establish priorities.
• Excellent written and verbal communication skills.
• Ability to communicate effectively with other departments as well as all levels of management.
• Solid analytical and problem-solving skills.
• Demonstrates continuous improvement and consistent metrics to achieve business results and quality output.
• Strong project management and organizational skills.
• Excellent attention to detail, resourceful, self-reliant, self-motivated, and confident.
• Ability to multi-task and adjust to frequent changes.
• Ability to be tactful, discreet and handle confidential info appropriately.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands, stoop and bend, reach, climb stairs.  The employee must occasionally lift and/or move up to 20 pounds. Use of vision is required for document/report inspection/analysis and visual observation of a computer monitor. Use of hearing and speech are necessary for telephone work. Ability to operate standard business and office equipment such as adding machines, copiers, calculators, typewriters, fax machines, etc.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• The noise level in the work environment is usually moderate. Lighting is usually fluorescent. Heating/Air Conditioning/Ventilation is usually adequate to accommodate the general office population.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.