Design Quality Engineer

Job Title:

Design Quality Engineer

Department:

Quality

Reports to:

Director, Quality & Regulatory Affairs

FLSA

SUMMARY:

The Design Quality Engineer is responsible for supporting technical aspects of the design process during the creation and/or remediation of Design History File documentation, qualification of the design to ensure it meets the design input requirements and quality review and approval for new or updated design specifications. The position works closely with Engineering, Manufacturing, Regulatory, and Product Management.

The role leverages proven competence and experience in quality systems requirements. This is a role that requires broad knowledge in QMS requirements and design and development activities in the medical device industry. This position requires broad technical skills, a structured mindset, versatility and an emphasis on quality and execution.

DUTIES AND RESPONSIBILITIES:

• Supports the creation of Design History File documentation that includes design input and output, traceability, risk file, verification & validation and design transfer.
• Collaborates with Manufacturing Engineering and stakeholders to implement design for manufacturability requirements.
• Supports technical design reviews throughout the product development process.
• Reviews and approves drawings and specifications on behalf of the Quality function.
• Provides Quality Engineering support to Sustaining Engineering projects.
• Provides Quality Engineering review and approval for Change Requests.
• Analyzes applicable medical device standards to ensure compliance.
• Develops and writes procedures and/or work instructions describing design, manufacturing, and inspection processes.
• Provides Quality support for the migration of paper system quality processes to using digital QMS tools.
• Conducts investigations of non-conformances and CAPAs; identifies root causes and implements corrective actions.
• Supports internal and external audits.
• Performs other related duties, as assigned.

REQUIREMENTS:

• Demonstrated process development and problem-solving skills.
• Ability to multi-task in an environment where responsibilities tend to encompass more than the job title would indicate.
• Understand ISO13485 and 21CFR part 820, part 11 requirements.
• Familiarity with RoHS, REACH, Prop 65, and UDI.
• Able to develop and maintain mutually respectful, cooperative working relationships with co-workers, customers and suppliers while promoting a positive company image.
• Experienced in Microsoft Office, ERP system experience, Microsoft Project.

SUPERVISORY RESPONSIBILITIES: Not Required

• Bachelor’s degree in engineering
• 5 years relevant experience
• Ability to read and interpret technical standards/regulations and write technical documents/reports.

The position is a sedentary job. The person must be comfortable sitting at a desk for long periods of time.

The work environment is a typical office environment.

• Light (typically <5%), including car or domestic flights.
• International flights possible.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LifeSync provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

The Age Discrimination in Employment Act (ADEA) forbids age discrimination against people who are age 40 or older. It does not protect workers under the age of 40, although some states have laws that protect younger workers from age discrimination. It is not illegal for an employer or other covered entity to favor an older worker over a younger one, even if both workers are age 40 or older.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.