Senior Engineer, Design Quality Assurance

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Chief Quality Officer
Type of employment:Permanent employment
Function:Quality Assurance
Location:Tel Aviv District, Israel
Reference Number:ISR_90001-07082026
Website:https://www.olympus.co.uk
Olympus is recruiting on behalf of BioProtect, its fully owned entity dedicated to advancing prostate cancer care through innovative spacing solutions.

As a Senior Design Quality Assurance Engineer, you will be responsible for the design, development and management of new products under development. Working with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. This role will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

Your responsibilities
Drive the design & execution of Production Release Process project for components & finished devices
- Lead and implement complex projects including quality improvement initiatives
- Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems
- Lead Process/Design Risk Analysis
- Lead product Design Control activities for new product development efforts
- Provide leadership in understanding of the quality regulations to other disciplines
- Support Process/Design Validation/Verification activities and approach including software validation
- Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting
- Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
Your qualification
Bachelors Degree in an Engineering discipline is required
- Minimum of 5 years experience in Quality Engineering in FDA regulated environment
- Knowledge of Six Sigma tools and problem solving
- Experience with sustaining engineering and post-market surveillance
- Knowledge of FDA QSR, ISO 13485, ISO 14971, ISO 11135, EU MDR
- Strong communication skills
- Ability to work in fast paced environment

Your competencies
Patient Focus - We put patients at the heart of everything
- Integrity - We do the right thing
- Innovation - We look for new ways to make things better
- Impact - We take accountability and get things done
- Empathy - We care for one another and work together
Your benefits
We offer a competitive salary and a locally competitive benefits package designed for employees based in Israel. In addition to statutory employment benefits, you'll have access to company benefits that support your wellbeing, development, and work-life balance. We'll be happy to share the full details during the interview process.
Further information:

We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to this role, to apply.