Design Quality Engineer II - Norwood, United States - BioTalent

BioTalent Norwood, United States

4 weeks ago

Description

Job Title:
Design Quality Engineer

Revision

Date:
07/25/2023

Work Location:
Norwood, MA

Department:
Quality

Reports to:
Quality Manager

FLSA Status:
Exempt

Summary:

The Design Quality Engineer (DQE) position plays a pivotal role in the development and implementation of quality assurance for all phases of the design process of our medical and life science instrumentation.

The DQE ensures that our products meet both external regulatory requirements and internal company standards. The DQE is the subject matter expert in design traceability, inputs, outputs, verification, and validation.

Essential Functions:
Develop and implement quality plans, verification and validation plans, and other quality documents for medical electrical equipment design projects.

Perform design reviews and risk assessments to identify potential quality and compliance issues.

Ensure complete design traceability from requirements gathering through to design outputs and post-market activities.

Collaborate with cross-functional teams to establish and maintain design inputs, outputs, and associated documentation in compliance with regulatory standards (such as FDA, ISO 13485, etc.).

Lead the verification and validation activities for medical devices, including protocol development, testing, and analysis of results.

Manage corrective and preventive actions (CAPA) related to design quality issues.

Facilitate the transition of new products from development to production, ensuring adherence to quality standards.

Stay up-to-date with regulatory changes and industry best practices regarding medical device quality assurance

Experience Requirements:
Minimum of 3 years of experience in quality engineering within the medical device industry, specifically with medical electrical equipment.

Profound understanding of medical device regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.).

Demonstrated expertise in design controls, with a strong focus on design traceability, inputs, outputs, verification, and validation processes.

Excellent analytical and problem-solving skills, with the ability to lead root cause analysis and implement effective solutions.

Strong interpersonal and communication skills, with the ability to work effectively in a team environment and interact with all levels of management.

Proficiency in statistical analysis software and quality management systems

Education Requirements:
Bachelor's degree in Science or Engineering.

Physical Requirements and Working Conditions:
Typical office environment with flexibility for travel as required to support the business.

Must be able to use basic office equipment: computer, printer, copier, telephone, etc.

Must be able to remain stationary for long periods of time.

Must be capable of communicating with stakeholders through various means.

Employee Signature:

Human Resources:

Date:

Date:

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

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