Senior Quality Engineer - CAPA
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 CAPA Quality Engineer is responsible for coordinating CAPAs, NCs and metrics gathering in support of Integra’s corporate CAPA program. This Quality Engineer will work with CAPA owners to conduct root cause investigations and develop action plans and effectiveness checks. This individual will also work with the Sr. Manager of CAPA, NC and Metrics to ensure that performance metrics assessing the health of the corporate quality system are collected and analyzed per schedules . The individual must possess the ability to establish and maintain effective working relationships with Integra QA, RA and Operations Team members worldwide.
Requirements
- Bachelor degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience.
- Computer skills to include knowledge and experience using Microsoft Office (or equivalent), Teams, Sharepoint and proficient use of contact sources for regulations and compliance on the worldwide web network.
- Experience with root cause analysis and problem-solving methodologies.
- Strong analytical and organizational skills.
- Excellent written and oral communication skills
- Ability to review and analyze documentation critically and logically.
Nice To Haves
- TrackWise use a plus.
Responsibilities
- Facilitate the tracking and closure of Corporate CAPAs addressing company-wide Corrective and Preventive actions.
- Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness
- Facilitate the tracking and closure of corporate Nonconformances (NCs) to ensure consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality and thoroughness of content.
- Coordinates across cross-functional CAPA / NC teams and ensures compliant and appropriate documentation of CAPA and NC activities from owners
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, may establish precedents and policies. Primarily hands-on worker, with instruction or supervision of others secondary to own technical work
- Recognized as a leader within the team, works on complex projects or processes with limited oversight. Manages and/or coordinates programs within the function contributing to the achieve of department goals and operating plans.
- Support Sr. Manager CAPA and Metrics by contributing to process improvements, innovative solutions, and training to standardize processes globally and to meet the changing regulatory compliance environment and compliance goals while minimizing complexity of implementation for Integra organizations
- Facilitate quality metrics gathering, analyzing and reporting on a regular and ad hoc basis.
- Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization (site, division and corporate) for input into NC / CAPA or for assessment of key quality system processes
- Maintain current knowledge of FDA and any other applicable international Quality System regulations for medical devices and human tissue products.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
