Randstad is looking to hire a Design Quality Engineer for a client of ours in the Medical Device Industry. This position is 100% remote 6 month long contract (potential to extend longer). The person in this position will provide risk management and design control guidance for design quality assurance activities on medical device projects, and coordinate quality activities with engineering, clinical, sourcing, and manufacturing, distribution, service, and support teams. You will support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices. This person will also provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects. Skills Required
- Working in disciplined, regulated industries. Medical device experience preferred.
- Expertise in FDA's 21 CFR 820/ISO 13485/14971/62304 standards
- Familiarity with IEC 60601 series of Medical Equipment Safety Standards.
- Familiarity with Problem solving, Investigations, Root Cause Analysis, Data analysis, Six-Sigma, Process control, failure modes effect analysis (FMEA) and other quality tools and techniques.
- Basic knowledge of Medical device International regulatory requirements
- Proactive engagement in finding and solving problems or preventing problem
- Teaming experience with positive outcomes
location: Monroeville, Pennsylvania
job type: Contract
salary: $1 - 50 per hour
work hours: 8am to 5pm
- Ensure that projects to develop medical devices follow applicable company policies,
- procedures, standards and regulations.
- Ensure that released devices are safe and effective and meet their intended use.
- Manage safety risks associated with medical devices in accordance with IEC 14971:2012.
- Manage post-release safety risks associated with complaints and returns.
- Facilitate usability analysis and activities in accordance with IEC 62366.
- Represent QA on product defect review boards, and change control boards.
- Help coach project teams on use of quality system.
- Prepare for and participate in project and quality systems audits and inspections.
- Facilitate analysis and activities associated with corporate privacy and security procedures
- Proactively participate in design reviews, quality business reviews and post market improvement teams.
- Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.
- Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions
- Experience level:
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.