Quality Systems Analyst
Description Summary: The Quality Systems Analyst continually improves the Quality Management System through the analysis of processes and the development of key performance indicators (metrics). S/he is a key contributor to Management Reviews. S/he manages the Purchasing Controls/Supplier Quality subsystem. The analyst seeks synergies and efficiencies as a super-user of all QMS software applications. The analyst leads the CSV/software validation efforts within NA. Essential Duties
Job Duties/Responsibilities:
Develop, improve, track, and report meaningful and actionable metrics for improving the Quality Management System.
Share ideas and collaborate with others throughout the companies to share best practices.
Provide key metrics to Management Review.
Set targets, analyze data trends, investigate anomalies, etc.
Develop, administer, and maintain the Purchasing Controls/Supplier Quality process for SNA.
Assure compliance with 21 CFR 820.50. Act as Purchasing Controls Subject Matter Expert during inspections/audits.
As software applications are adopted for the QMS, act as super-user/SME. Understand underlying processes and formulate local User Requirements Specifications.
Lead the Computer System Validation (CSV)/Software Validation program for SNA.
Act as SME on this topic during audits and inspections.
Assure compliance with 21 CFR 820.70(i) and 21 CFR Part 11.
Maintain knowledge and training required to perform internal audits.
Assist with internal audits as necessary.
Increase/maintain knowledge of applicable FDA, Health Canada, and ISO laws, standards, and expectations.
Continually challenge QMS processes and recommend improvements for better compliance and efficiency.
Perform Biennial document reviews.
Education/Experience:
Bachelor’s Degree in Engineering, Science, or related field required. Master’s degree a plus.
Minimum of 5-7 years’ experience in a regulated industry (e.g. Medical Device, Pharmaceutical, Aerospace, etc.)
Prior QMS experience or formal quality systems training is required.
ASQ certifications a plus. Internal auditor certifications a plus. Quality training certificates (e.g. ASQ) a plus.
Skills:
Strong analytical skills a must
Mastery of Excel and analytical tools required. Ability to quickly learn new
software platforms is required. Proficiency with graphical presentation software a strong plus.
Ability to present complex data to all levels of the organization in a clear and
understandable way is required.
Travel: Up to 15% travel may be required.
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