Note: The job is a remote job and is open to candidates in USA. Heraeus Electro-Nite is a family-owned global technology leader dedicated to driving innovation across key industries. They are seeking a Design Assurance & Quality Engineer to lead product development, manage design controls, and ensure quality compliance in the medical device sector.
Responsibilities
- Lead and implement product development, including the application of design controls, for new products and existing product changes including line extensions
- Create and maintain the design history file (DHF), including development of related specifications such as user requirements and design specifications
- Plan, implement, and report on design verification and validation studies, including bench and pre-clinical test protocols and reports
- Lead the development of manufacturing documentation and manufacturing process validation activities
- Responsible for risk management activities from product concept through commercialization
- Partner with Regulatory to support submissions for pre-market authorizations in the US
- Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements
- Perform lot release, including reviewing batch records, device history records (DHRs), and process documentation for accuracy and completeness
- Support the intake, evaluation, and documentation of nonconforming materials
- Support post-market phase including product complaint handling, risk management, and post-market surveillance activities
- Help conduct supplier qualification and performance evaluation activities
- Communicate quality issues to suppliers and support resolution tasks
- Assist with internal audits and support external audits and inspections (e.g., FDA, ISO)
- Participate in CAPA investigations and track CAPA progress through verification of effectiveness
- Help provide QMS training and subject matter support for fellow employees
- Administer user set up and employee training in QMS support software and monitor training
- Serve as document control coordinator in QMS support software
- Identify opportunities to improve processes, reduce defects, and enhance overall product quality
- Monitor and trend quality metrics and escalate signals
Skills
- Bachelor's degree in life sciences, material sciences, engineering or a related field required
- Experience in medical device industry required; minimum 3 years preferred
- Working knowledge of design controls and general knowledge of the ISO 13485 standard; formal ISO 13485 training is a plus
- Experience in a small company or start-up environment preferred
- Experience with QMS support software / document control systems is a plus
Company Overview
How do steel makers save energy and become more sustainable? How do foundries become more efficient and optimize their processes? Heraeus Electro-Nite (HEN) provides solutions for the molten metal industry. It was founded in 1933, and is headquartered in Houthalen, Limburg, BE, with a workforce of 1001-5000 employees. Its website is https://www.heraeus-electro-nite.com/.