Senior Quality Systems Engineer

Description:

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Supports maintenance of the Quality management System, ensuring compliance to regulations and internal site and global procedures. Identifies gaps in the QMS and drives improvements to close gaps.

• Maintains the Quality Manual and site Quality System related procedures, ensuring contents are compliant and appropriate for the business.

• Analyzes current and future procedural needs of the business.

• Organizes and manages the plant internal audit system as the site Internal Audit Manager.

• Conducts Quality System Audits and assists in training/guidance to other internal auditors.

• Supports external Quality System audits in key roles. Provides support and subject matter expertise during audits and inspections.

• Assists in the initiation, processing, and completion of CAPA records in the electronic system.

• Leads meetings and communications for CAPA updates, information, and concerns to keep CAPA timelines on track.

• Responsible for collecting and reporting Quality Metrics on regular basis in accordance with established procedures.

• Independently investigates, gathers data, and performs preliminary data analyses.

• Reports on Key Performance Indicators to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.

• Provides experienced quality assurance support to manufacturing, product development teams, procurement, and other functional areas.

• Mentors lower-level Quality Engineers.

• Provides training of quality awareness and quality processes.

• Promotes the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), and Measure System Analysis.

• Keeps up with current and developing manufacturing and engineering trends that concern product quality.

• Undertakes special projects as required and contributes to continuous improvement activities.

• Supports and lead process improvement activities.

• Writes reports and presents progress at project meetings.

• Achieves goals within established budgets.

• Plans projects or subtasks so they may be tracked and presented.

• Attends various meetings and actions/communicates instructions and follow-ups.

• Independently determines approach for completion of assigned tasks.

• Coordinates and leads Quality Review meetings.

• Communicates confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.