Are you looking for a new challenge in a Quality Design Assurance within medical device industry? Are you keen on working for the overall quality engineering of new product development and product maintenance? We might have what you are looking for!
In this roll you will ensures the supervision of a team of several quality engineers, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills. Represents the Quality management Function on Project Teams for both new product development and existing products. Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements. Defines appropriate metrics to measure progress and to define yearly objectives.
This position is also responsible for resolving complex problems and driving quality engineering improvements.
- Ensuresthatthefollowingactivitiesareperformedthruprojectqualityengineers' management:
- Evaluation of user needs and product requirements to identify applicable quality standards
- Development of quality plans
- Projects related Risk management activities
- Ensuring design control elements are satisfied
- Ensuring process validation activities are completed appropriately and make the link with product design whenever needed.
- Define product control strategy
- Evaluation of test methods used in project activities
- Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports. Assist / conduct Failure investigations and problem-solving sessions
- Assist/conduct Failure investigations and problem-solving session
- Continue to build Quality Management leadership and technical capability throughout the organization by integrating, aligning, and increasing the rigor of quality engineering processes across the global organization
- Support investigation for Issues related to product design.
- Can be part of internal or external quality audit team
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- Engineer with a degree in Quality Management
- 10 years industry experience (Healthcare/Pharmaceutical/Biologics/Medical Devices)
- Management experience
- Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
- General understanding of Design Control, DFSS
- Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management
- Understanding of industry regulations/standards: ISO 13485, QSR, 21CFR820, ISO 60601, 62304, 62336
- Rigor and good organization
- Ability to act as Change Agent and effectively manage change
- Strong interpersonal skills : Demonstrate strong and clear accountability for successful and timely completion of tasks
- Influence: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion and timing skills. Remain open to be persuaded when appropriate.
- Prefer infusion pump experience or drug delivery experience (regulated FDA industry)
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17178