Quality Systems Engineer

Overview

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• Under the direction of the Quality Management Representative, performs assigned duties and responsibilities promoting continuous improvement of the Quality Management System.
• Schedules, conducts and directs internal audits (QMS, product, or process) and follow-up audits of various product groups and subsidiaries. May conduct or assist with supplier audits as needed.
• Verifies the Analogic QMS meets requirements of ISO 9001, ISO 13485, 21 CFR 820, MDR and other regulatory/industry standards in support of all Analogic and subsidiary products and services.
• Generates and maintains the Corporate Quality Manual and Corporate Quality Procedures necessary to support compliance and certification to ISO/GMP/MDR and other related industry standards.
• Plans and supervises second/third party audits from ISO registrars, FDA, customers, and others as required.
• Reviews, approves, and makes recommendations for the generation and continuous improvement of QMS non-product specific documentation supporting corporate, product group and subsidiaries.
• Works with all disciplines on Corrective and Preventive Action (CAPA) resolutions and may support product issues such as recalls, notices and field complaint investigations/reporting to authorities.
• Mentors quality engineers, inspectors, and other team members in all aspects of the QMS including audits, CAPA, procedure generation, and the corporate product development lifecycle process.
• Supports the periodic Management Review process.
• Supports other administrative activities for the Quality Department as necessary.

• BS in Engineering or technical discipline with at least 4 years  experience in Quality Systems Engineering or equivalent combination of education and experience. 2+ years of experience in the medical device manufacturing industry a plus.
• ASQ Certified Quality Auditor or equivalent with experience as a lead auditor preferred.
• Strong working knowledge of ISO 9001, ISO 13485, 21 CFR Part 820, MDR and other requirements.
• Ability to generate and update procedures that support a modern best-in-class QMS.
• Excellent interpersonal, verbal, and written communication skills with a strong ability to multitask in support of cross-functional teams having various levels of QMS understanding.
• Highly detail oriented with strong organization, leadership, project management, training, conflict resolution skills with demonstrated ability to self-manage and prioritize competing priorities.
• Expert level of experience with trouble-shooting and applying effective, systematic problem-solving methodologies to identify, prioritize, communicate and resolve complex quality issues.
• Risk management, reliability, verification, validation and design review experience a plus.
• Demonstrated proficiency with process flow mapping and team mentoring.
• Demonstrated proficiency with Word, Excel, PowerPoint, Access, Agile, Minitab and SAP including experience creating and working with databases, queries and reports.
• Lean and/or Six sigma training and certification is a plus.

Associate

Contract

• Quality Assurance

• Pharmaceutical Manufacturing