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 Senior 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 Complaint, CAPA, Audit, and Quality Planning processes, acting as the Internal Audit Manager, and providing experienced quality assurance support to manufacturing and product development teams as well as lower-level Quality Engineers. This role will provide training on QMS processes to the organization, champion the QMS and work on many phases or sub-tasks of projects or entire projects.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.
Provide 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.
Support 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.
DESIRED MINIMUM QUALIFICATIONS:
Bachelors in a scientific discipline required with minimum of 5 years' experience in the medical device or pharmaceutical industry. Years of experience and education combined, or relevant experience may be considered in lieu of a degree.
Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards.
Strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education.
Strong knowledge of CAPA processes and requirements. Previous experience documenting, reviewing and approving CAPAs required. Previous experience managing CAPA process desired.
Previous experience providing Quality Systems and CAPA training required.
Quality Systems/Assurance experience and demonstrated use of quality tools/methodologies.
Previous experience in high volume manufacturing environment.
Demonstrated project management and leadership skills, including the ability to lead cross-functional project teams and resolve quality related issues in a timely and effective manner.
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.SUPERVISION RECEIVED:This position is under the direct supervision of the Quality Systems Manager. Works independently under general supervision, reviewed at project milestone and/or completion by senior management.Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/adaveteransemployers.cfm)Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
