Sr. Quality Systems Engineer

This position is responsible for leading and supporting efforts to maintain Quality Management System compliance, as well as ensuring compliance with applicable regulatory and statutory requirements. Must be able to work independently and resolve regulatory compliance and quality program related issues in a creative, high quality, timely and cost-effective manner. This position reports to the Sr. Quality Manager - Dx.

DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS

• Develop, review and approve Quality System documents/SOPs/work instructions as required. Review Engineering Change Orders and Device History Records supporting device design and manufacturing, and communicate necessary changes to applicable department representatives to maintain compliance. Work with other departments to train and educate where necessary to ensure procedures are adequate.
• Support New Product Introduction design & development meetings; create/review/approve device master records, quality control plans, engineering/production risk analysis, labeling, engineering verification & validation reports, production process validation reports, and engineering change orders for adequacy/compliance prior to device transfer to production.
• Lead internal audit program, including internal audit scheduling, planning, corrective action initiation and reporting to site management status of internal audit program. Lead and participate in internal audits.
• Provides mentorship to CAPA owners to ensure compliant and timely records through sound problem-solving practices and scientific methods.
• Perform/supervise investigations into product incident reports of internal & external events, with emphasis on use of root cause and/or other analysis tools and verify effectiveness of implemented corrective actions to prevent recurrence of adverse events.
• Lead Management Review meetings with Quality Management support, and develop Management Review presentation materials and meeting results/minutes.
• Support Quality System audits/inspections by external auditors; support FDA back room activities.
• Recommend process improvements and lead teams and initiatives to actively drive compliance and product/process quality.
• Provides support in general quality program issues to support Quality Department effectiveness.