Quality System Analyst Job in Northern 22645, Virginia Us
Position Summary:
The Quality Systems Analyst is responsible for the deployment, continual improvement, and administration of the company’s Quality System while ensuring regulatory compliance with 21 CFR 820 and ISO13485.
Primary Responsibilities:
§ Manages the Quality System through continual process improvement.
§ Ensures regulatory compliance and the site’s understanding of the quality system through internal audits, company-wide Quality System training and the Corrective and Preventive Action process.
§ Develops, implements, monitors and maintains the internal quality audit schedule including the assignment of auditors. Leads internal audits as needed.
§ Supports or lead the efforts for conducting supplier audits including managing any subsequent follow up actions or corrective/preventive actions.
§ Develops, implements, monitors and maintains quality metrics (weekly, monthly, quarterly) related to corrective actions, preventive actions, discrepant materials, internal audits, complaints (service and technical) and validation to provide an early warning feedback system to achieve quality objectives.
§ Responsible for collecting and analyzing data in support of the Management Reviews. Responsible for the creation and issuance of the Management Review, including the issuance of meeting minutes and review certification.
§ Responsible for the implementation and maintenance of the nonconformance system. Chairs and leads the Material Review Board to drive the timely resolution and closure of discrepancy reports (DRs). Assesses DRs to ensure meaningful data is included in the report (completeness of description, evaluation and adequate justification for final disposition of material).
§ Supports the efforts/teams focused on identifying the primary root causes using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc) and implementing corrective and preventive actions to reduce the number of customer complaints, internal audit findings and nonconforming material.
§ Responsible for the implementation and maintenance of the Corrective and Preventive Action system. Initiates and brings to closure all corrective and preventive actions resulting from the analysis of quality data including audits, management reviews, manufacturing reports, supplier activities, and customer complaints.
Minimum Requirements/Qualifications:
- B.S. or B.A. degree
- The required skills, knowledge and abilities are typically acquired through a minimum of 5-8 years medical device experience in quality assurance.
- Knowledge of the overall regulatory requirements associated with the development, production and sale of diagnostic medical products into worldwide markets.
- Strong facilitation skills
- Must have experience and knowledge of ISO 13485:2003; 21 CFR Part 820; IVD Directive; and Canadian MDR.
- Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.
- ASQ Quality Improvement Certification and ASQ Certified Quality Auditor Certification preferred.
Physical Requirements:
· Normal office environment.
· Position may require frequent communication and walking to other areas in which designated PPE will be required. Position will require sitting and standing.
· Additional PPE will be required when working with potentially infectious material or chemical hazards.
· Employee may occasionally lift and/or move up to 10 pounds.