Quality Systems Engineer

Job Description:

• Conducts internal audits of the Quality Management System at the corporate, product group, and subsidiary levels.
• The support of these functions also includes Management of third party registered body contracts and planning, planning and execution of external customer and registered body audits, oversight of the Operational Documentation System, and resolution of QMS/CAPA issues.

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.
• Patriciates in and supports the periodic Management Review process.
• Support 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, 21CFR 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 detailed 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.