Product Quality Engineer I

Drager is hiring a Product Quality Engineer to work hybrid in our Andover, MA office.

We are seeking a Product Quality Engineer Provides quality support for product lifecycle sustaining and new product development activities of medical device products. The Quality Engineer will provide quality and compliance support to the product development teams and ensuring the product meets customer specifications. The engineer is primarily responsible in achieving the highest quality level of all parts, products and systems while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. Ensure that all applicable regulatory standards and directives are applied and managed in Draeger Medical Systems Incorporated (DMSI).

Responsibilities

• As a Quality Assurance representative on project teams, ensure the cross-functional teams follow design controls requirements and internal procedures/standards.
• Review and approve design control documentation in accordance with defined procedures. Ensure results demonstrate compliance to medical device standards and established customer and technical requirements. Maintain compliance and continuously improve the QMS regarding ISO 9001, ISO 13485, and US FDA requirements and further regulatory requirements which apply to the facility.
• Support product risk management and product security requirements in accordance with applicable standards, regulations and guidance. Develop, execute, monitor, review, and report on product CAPA plans related to life cycle management/engineering activities
• Supporting the product development or operations team by providing analysis and expertise as required to support Draeger
• Identifying root causes of problems in the production process; recommends and/or implements corrective measures. Serve as the authorized Quality Assurance approver of changes.
• Provide quality engineering expertise to maintain and improve product quality by supporting customer complaints investigations. Prepare Health Hazard Evaluation when appropriate. Analyzing data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects. Ensuring manufacturing processes comply with federal, state, local, and industry standards and regulations
• Review technical publications, articles, and abstracts to stay abreast of technical developments in industry and the regulatory landscape.
• Monitor and improve Quality Management reporting systems to meet US region and business unit requirements while maintaining consistency with global Draeger Medical systems. Communicate this information to local and global management. Support all third-party inspections and audits (Notified Body, FDA, etc.).
• Work with Cross-Functional Teams to ensure quality objectives are understood and achieved. Additionally, ensure that escalations are resolved in a timely manner. Take responsibility for individual CAPA's and provide input into CAPA's as appropriate. May facilitate the CAPA program for a particular product/project.
• Performs other duties as needed and assigned.

• BS in related technical or engineering discipline.
• 0-3 years' experience in a Technical or Quality discipline
• Root-cause determination and solution recommendation through applied statistical methodology or quality tools
• Medical or life science product familiarity

The targeted pay range for this position is typically between $74,800 - $86,000. We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job-related knowledge, skills, experience, and other objective business considerations. This position is eligible for the following additional compensation: annual bonus.