Katalyst CRO
Overview
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Quality Systems Engineer
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Katalyst CRO Responsibilities
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. Requirements
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. Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Join to apply for the
Quality Systems Engineer
role at
Katalyst CRO Responsibilities
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. Requirements
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. Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr