Senior Quality Systems Engineer

Integra LifeSciences•Mansfield, MA

About The Position

Changing lives. Building Careers. 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. The Sr. Quality Systems Engineer is responsible for supporting the site Quality Management System (QMS). Primary responsibilities include driving improvements to the QMS, having oversight of and ensuring compliance to the CAPA, NC and Quality Planning (QP) processes, and providing experienced quality assurance support to manufacturing and product development teams as well as lower-level Quality Engineers.

Requirements

Bachelors in a scientific discipline required with minimum of 5 years' experience preferably in the medical device industry; strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education.
Previous NC and/or quality systems/assurance/engineering experience and demonstrated use of quality tools/methodologies.
Detailed knowledge of FDA Quality Systems Regulations, ISO 13485 and other global regulations and standards.
Previous experience in high volume manufacturing environment.
Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.
Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.
Must be able to read and write in English.

Responsibilities

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.
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 NC records in the electronic system.
Leads meetings and communications for NC updates, information and concerns to keep NC 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, as necessary.
Keeps up with current and developing Quality Management System trends and changes and collaboratively implements those changes into the QMS.
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.