Quality Systems Engineer I
Quality Systems Engineer I
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Engineering professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Vice President, Quality at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
The Quality Systems Department manages Change Control, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapies products. Staff works closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation is compliant with regulations, procedures and policies.
This individual will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with Manufacturing, Engineering, Facilities and Validations.
- Support revision of procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies.
- Apply and maintain quality standards and procedures for quality systems.
- Review executed cGMP documents and participate in the implementation of systems for the acquisition, processing and storage of cGMP information.
- Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).
Key Functions may be in support of one or more of the following:
Change Control/Design Control:
- Support the process of change control approval from evaluation of an initial proposal through approval, implementation, closure and effectiveness review.
- Provide QA support of change controls to ensure that they meet the requirements of Vericel standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a quality management system electronic workflow.
- Apply and interpret Vericel procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects.
- Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes.
- Assist in the management of the Design Control program, updates to Design History Files, and participate as a Quality representative in the design review process.
- Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.
- Assist with driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
- Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies.
- Participate in the risk assessment process as it relates to assisting with categorizing risk and assigning report numbers.
- Provide clear and concise reports of risk management activities/ assignments throughout the site and provide key metrics that monitor compliance for the risk management program.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership qualifications include, among other requirements:
- Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor’s degree or equivalent with 1+ years of cGMP experience.
- Prior experience working in a Quality/Compliance role within the pharmaceutical or medical device industry.
- Experience writing and reviewing technical cGMP documents.
- Experience with an electronic Quality/Document Management System.
- Strong written and verbal communication.
- Experience operating in an environment with strict timelines.
- Advanced proficiency in basic Microsoft Office applications: Word, Excel, PowerPoint
- Familiarity with advanced Microsoft Office applications: Visio, Project, Access.
- A strong understanding of Medical Device and Biologics FDA regulations.
- Strong working knowledge of quality management systems.
- Proven Risk Management/FMEA experience/knowledge.
- Good project management skills and working knowledge of statistical techniques.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Occasional overtime may be required in support of site inspections.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.