Quality Systems Specialist
Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, St. Paul, San Francisco, Los Gatos, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, in vitro diagnostic (IVD) products, combination products, and consumer healthcare products. We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: Quality Systems Specialist - Providence, RI
Nature of Role: Reporting to the Quality Systems Manager, the Quality Systems Specialist provides company leadership in the maintenance and improvement of corporate-wide quality management systems and support processes. S/he proactively manages the various elements of the quality system to ensure compliance to applicable national and international quality system regulations.
- Support the Quality Systems Manager to provide hands-on ownership for the various elements of the Ximedica Quality Management System including corrective and preventive action (CAPA), customer complaints, and/or internal audits etc. to ensure successful performance during third-party audits.
- Ownership of CAPAs, customer complaints, audit findings, and/or internal audits.
- Compile and track appropriate metrics and data to demonstrate Quality Management System compliance
- Support Quality Systems Coordinator in following up and ensure timely closure of CAPA’s, Audit Findings, etc.
- Ability to support monthly operations meetings by compiling and presenting metrics.
- Review and approve Internal and External audit reports, as well as, any audit findings.
- Perform Risk Assessments for quality observations.
- Ability to perform Quality System Software Validations, as needed.
- Bachelor’s Degree or higher in an Engineering discipline or equivalent experience required.
- Minimum of 3 years relevant experience in Quality Systems in a new product development, medical device environment.
- Direct experience with ISO 13485 and FDA QSRs required.
- Experience with performing GAP analysis (i.e. translating regulations into Ximedica SOPs) required.
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, clients, and customers.
- Strong investigational and communication skills, with a strong skillset to document investigations, perform root cause analysis, and determine corrective actions plans.
- Demonstrated working knowledge of Quality Management Systems requirements, and process ownership, preferred.
- Certified Internal Auditor, preferred.
- Technical Writing Experience, preferred.
- Experience with Value Stream Mapping and Overall Process Improvement preferred.
Please note: JOB CODE: #844PVD when applying
Send resume to: [email protected].
EQUAL OPPORTUNITY EMPLOYERXimedica provides equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.