Design Assurance and Continuous Improvement

2 months ago


Runcorn, United Kingdom Epredia Full time

Epredia, a global leader in providing solutions for cancer diagnostics, is dedicated to improving lives by enabling our customers to achieve diagnostic excellence. We’re growing quickly and constantly expanding our team. Find a rewarding career with a diverse group of individuals that share a passion to do work that matters and positively impacts patient lives.

**Job Description**:
Job Title:
Design Assurance and Continuous Improvement Specialist

**Location**:
Runcorn, UK

Position Summary:
The Design Assurance and Continuous Improvement Specialist manages the procedures covering all phases of the R&D lifecycle, including Product Development Process (PDP), also referred to as Design Controls. The position shall develop and maintain the design management process across the R&D teams located at multiple sites. The role shall work within Design Assurance as part of the R&D team. They provide autonomous assessments/evaluations and collaborates with support functions to achieve results.

Essential Job Functions and Accountabilities:

- Process
- Develops and maintains the R&D Procedures ensuring conformance to regulatory and industry standards as a bedrock to Design Assurance
- Creates training materials and delivers training to all staff interacting with the R&D processes
- Collaborates with QA departments and R&D managers to ensure R&D documentation is in compliance with R&D Procedures
- Co-ordinates and implements process improvements,
- Co-ordinates and implements Continuous Improvement activities to establish and reinforce a culture of Design Excellence within the R&D teams,
- Supports technical leadership for problem solving
- Monitors trends in the global environmental and safety regulations for products
- Identifies compliance threats and ensures mitigations,
- Ensures that compliance to all applicable regulations, standards are maintained and evidenced,
- Qualifications/Skills

Essential:

- BSc degree in a relevant discipline e.g. (Mechanical, Electronics, Software Engineering)
- Understands and is driven by the industry requirements for IVDR/Medical Devices,
- In depth knowledge of 21 CFR 820, 21 CFR 11 and ISO 13485 associated with the medical device industry,
- In depth knowledge of environmental requirements including, but not limited to, OSHA GHS, RoHS, REACH CLP.
- Understanding and experience with Design Controls,
- Experience in Product Development projects,
- Problem solving

Desirable:

- Strong interpersonal skills with a proven ability to collaborate with others in multi-disciplinary team settings, influence decision making, and build group consensus,
- Excellent written and oral communication skills.
- Experience in Design & Regulatory Compliance activities for market releases and product maintenance,
- Understanding of the Risk Management process.

YOUR APPLICATION

TO ALL RECRUITMENT AGENCIES

Epredia does not accept unsolicited third party resumes.

Epredia is an Equal Opportunity Employer.



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