What are the responsibilities and job description for the Quality Engineer position at RTI Surgical Inc?
While this is intended to accurately reflect the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
COMPANY SUMMARY:
RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana; Eden Prairie, Minnesota; Glencoe, Minnesota and Neunkirchen, Germany.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:
• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
Primary Function:
This position brings value to the organization by providing thorough technical review of all documents generated for inclusion in the Design History Files and process validation files, as well as for investigating customer complaints. The person(s) in this position will play a critical role in evaluating risks impacting the CBI quality system. Additionally, this position will perform related duties as determined by the department manager.
Essential Job Functions/Duties:
Responsibility:
- Supports design control by:
- Participation in design reviews and design input discussions
- Participation in protocol development
- Review and approval of all documents generated in the development of the Design History File for protocol fulfillment, statistical validity, regulatory compliance and auditability
- Participation in risk management activities
- Review and approval of all process validation protocols and reports
- Review and close customer complaints, assist in investigation of non-clinical complaints
- Conduct risk assessment pertaining to CAPA’s, complaints, NCMR’s, deviations, etc.
- Active participation in CAPA resolution and determining effectiveness
- Collaborate with Clinical, Engineering, Regulatory and Operations personnel to perform complaint investigations
- Evaluate / audit new production processes for critical control points and recommend solutions
- Sponsor / coordinate CAPA activities
- Participate in internal audits
Knowledge:
- Understand and apply the understanding of FDA QSR, MDSAP, Canadian and ISO 13485 Quality System
- Requirements in carrying out duties
- Understands and deploys best practices associated Quality engineering processes
- Collaboration
- Collaborate with Clinical, Engineering, Regulatory and Operations personnel to perform complaint investigations
- Collaborates within the QA team and others not part of the QA team
- Change / Innovation
- Proposes ideas and implements incremental improvements
Decision Making
- Moderately independent, consults supervisor
- Minimum Work Experience/Educational Requirements:
- Collaborate with Clinical, Engineering, Regulatory and
- Operations personnel to perform complaint investigations
- Evaluate / audit new production processes for critical control points and recommend solutions
- Sponsor / coordinate CAPA activities
- Participate in internal audits
Physical Requirements/Work Environment:
- Must be able to perform the essential functions of the job, with or without reasonable accommodations
- Limited exposure to hazardous chemicals used in the manufacture of the product
- Physical demands are typical of an office and classroom environment
