About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
Brief Description
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
The Principal Quality Systems Engineer will be part of the Regulatory Compliance Work Stream. Responsible for establishing Quality System with focus on both standard compliance (21 CFR 820, ISO 13485) as well as regulatory compliance.
What You’ll Do
- Lead quality systems related projects and serve as a company champion towards client quality improvement initiatives
- Partner with key stakeholders to resolve complex non-compliant issues by the most efficient and effective methods
- Support the development of customizable QMS SOPs and templates
- Establish Quality Management Systems policies and procedures at different clients
- Develop success metrics for quality initiatives
- Develop or support in writing proposals for quality related projects
- Collaborate with clients to help ensure compliance with national and international standards and legislation
- Understand the regulations and policies regarding product registration in the countries where the client company has businesses, emerging markets, and keep track of the changes in the regulations and processes.
- Remain abreast of changes in relevant regulations including product testing, clinical trial, product registration and post-marketing action both proposed and implemented
- Establish Quality audit program and define sustainable and effective audit schedule and audit plans to deploy at client site
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analyses
- Develop and provide 21CFR820 and ISO13485, Risk Management, etc. QMS related training
- Support project teams with development of QSI documents and SOPs
- Audit drafted QSI documents and SPs
- Map regulatory requirements (per 21CFR820 and ISO13485) to draft QSI documents and SOPs to ensure compliance to the regulations
- Finalize all QSI documents and SOPs
- Conduct DHF Reviews
- Develop and finalize a QSIT audit checklist that can be utilized for future FDA QSIT audits.
- Develop a Field Corrective Actions (FCA) Standardized Value Stream Process Map for client using archival data
- Develop an FCA Standardization Roadmap defining which processes to standardize and timing for implementation
- Identify Process Business Requirements for each step of the process roadmap
- Develop a Standardized FCA Procedure
- Conduct internal audits (standards and process) suppliers audits
- Assists in special projects as needed.
What We Look For
- Communication (Written /Oral) – Ability to communicate effectively in written and oral form. Excellent report writing skills are essential.
- Proven ability to find solutions and problem solve proactively with work or project related scenarios.
- Demonstrated ability to develop and sustain positive relationships with internal as well as external customers.
- Advanced computer skills including MS Office applications (Word/Excel/Visio/PowerPoint/Project) are required. Experience with Agile PLM or other electronic documentation management systems desired.
- Bachelor’s degree in engineering or equivalent work experience.
- A minimum of ten (10 provide regulatory training, guidance) years of directly related experience in Quality System in a regulated industry environment.
- Experience with conducting audits with focus on both standard compliance as well as process compliance. Support back and front room activities during notified body audits.
- Demonstrate SME level understanding of ISO 9001, 13485, 14971, 21 CFR part 820, 210, 211, and 11. Certified Quality Auditor (CQA) certification highly desirable.
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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Senior Project Manager - Medical Device #5623 in Chipping Norton employer: ECI
At ECI, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. Our commitment to employee growth is evident through continuous training opportunities and a supportive environment that encourages professional development. Located in a vibrant area, our 24/7 monitoring team enjoys the unique advantage of working with cutting-edge technology while contributing to meaningful projects in the financial services sector.
