Medical Device Quality Assurance Specialist

3 semanas atrás


Coimbra, Coimbra, Portugal Smith+Nephew Tempo inteiro
Life Unlimited at Smith+Nephew: We design and manufacture technology that pushes the limits of living. Our Design Quality Engineer is responsible for implementing, supporting, and sustaining our quality system. This role will ensure that medical device regulations, standards, and guidelines align with our procedures.

Key Responsibilities:

* Analyze post-market surveillance data to identify trends and verify product performance within established risk profiles.
* Perform routine updates of product risk management files per Smith and Nephew procedures.
* Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions.
* Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products.
* Assist in the preparation and coordination of internal and external audits to international and US standards and quality policies and procedures.

Requirements:

* Bachelor's degree in science, engineering, or a related field.
* 2 years minimum experience in the medical device or related industry.
* Portuguese and English proficiency.
* Strong decision-making and attention to detail skills.
* Ability to provide and implement solutions to quality problems.
* Effective written and oral communication skills.
* Team player with MS Office, MS Excel, and statistical software proficiency.

What We Offer:

* Generous annual bonus and save-as-you-earn share options.
* Flexible vacation and time-off policy.
* Paid holidays and volunteering hours.
* Hybrid working model.
* Hands-on training and mentorship.

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