- Philips (Plymouth, MN)
- …You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance /Control, detailed knowledge of Risk ... The Senior Design Assurance Engineer will play a critical role in...to Design/Process Controls. + You have strong understanding of Medical Device QSR regulations/standards including ISO 13485,… more
- Owens & Minor (Toano, VA)
- …success starts with our teammates. Owens & Minor teammate benefits include: + Medical , dental, and vision insurance, available on first working day + 401(k), ... non-conforming products and assembly. **ESSENTIAL JOB FUNCTIONS:** 1. Supports the company's Quality Policy, Mission Statement, and ISO Quality System. 2.… more
- Mentor Technical Group (Juncos, PR)
- …the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, ... Mexico, Germany, Canada, and South America. Responsibilities: + Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control). +… more
- Mentor Technical Group (Juncos, PR)
- …the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, ... Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review… more
- Insight Global (Maple Grove, MN)
- …a related field; Master's preferred. . Minimum of 5 years of experience in design assurance within the medical device industry. . In-depth understanding of ... Job Description Insight Global is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product… more
- Medtronic (Mounds View, MN)
- …equivalent certification is preferred. + **Experience:** Experience in Quality Assurance , Engineering, Capital equipment + **Industry Experience:** Medical ... ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This...device industry. + **Technical Skills:** Proficient in quality assurance practices, risk management, and regulatory… more
- Owens & Minor (Toano, VA)
- …success starts with our teammates. Owens & Minor teammate benefits include: + Medical , dental, and vision insurance, available on first working day + 401(k), ... reports audit and inspection results. **Core Responsibilities** + Product inspection to Device Master Record. + Data preparation for analysis and presentation by… more
- Abbott (Plymouth, MN)
- …Knowledge of FDA, GMP, ISO 13485, IEC 60601, ISO 14971. + Prior medical device experience, especially electrophysiology or cardiovascular devices preferred. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Huntington Ingalls Industries (Fort Meade, MD)
- …challenges. Leads small-scale projects, working groups, and operational initiatives. Quality & Compliance: Ensures high standards in documentation, reporting, and ... Expert Consultation: Expert understanding of 802.11 systems, Personal Electronic Device signature(s)/hardening, VPN/VPS architecture, and use of electronics in… more
- Mentor Technical Group (Caguas, PR)
- …of (7) seven years' experience in manufacturing, quality control, quality assurance , or regulatory compliance, preferably in the medical device or ... the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas,… more