Product Release Associate
hace 1 semana
**Company Description**:
At Intuitive, we are united behind our mission: we believe that mínimally invasive care is life-enhancing care.
Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference.
For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds.
We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect.We lead with inclusion and empower our team members to do their best work as theirmost authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways.
We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients.
Together,let's advance the world of mínimally invasive care.
**Primary Function of Position**:
The Quality Control department is devoted to verifying that manufactured products meet specification and are produced in accordance with all requirements.
The Quality Assurance Associate will work with a team of dedicated individuals within Production to assure compliance to of finished product quality system requirements; to identify discrepancies related to traceability, rework, ECO and Deviation implementation, and drive resolution of such discrepancies; and to authorize release of product to customers.
**Roles & Responsibilities**:
- Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements.
- Releases ISI products, including Instruments and Accessories for distribution according to the stablished procedures.
- Reviews and approves shipments of Single Use Devices to the sterilization process with the sterilizer contractor.
- Reviews, approves and releases sterile products from Intuitive or from a Contract Manufacturer.
- Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system.
- Works collaboratively with internal and external customers to resolve non-conformances on a timely manner.
- Escalates areas of concern to the Quality Assurance department and direct management.
- Performs all work according to Quality standards as set by the Quality Assurance department and direct management.
- Performs all work according to production, planning and logistics schedule, including working overtime as required.
- Escalating to the Quality Assurance department and direct management all Quality issues that could impact patient safety, surgical efficacy or traceability.
- Compliance with company department and standard operation procedures.
Supports internal and external audits as required.
**Qualifications**:**
Skills, Experience, Education, & Training**:
- High School, Technical Diploma or Bachelor's degree.
- 1-year relevant experience in QA/QC role within a medical device company.
- Ability to read English, read and comprehend instructions, write short correspondences and memos, complete quality documentation in English and Spanish, effectively present information in one on one and small group situations involving employees, supervisors or engineers.
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820 and ISO 13485.
- Demonstrated ability to be a quick learner and understand complex products and processes.
- Exceptional analytical, problem-solving, and root-cause analysis skills.
- Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions and when dealing with others.
- Demonstrated ability to work independently and with mínimal supervision, multi-task, and handle tasks with competing priorities effectively.
- Very strong computer skills and experience with Windows operating system and Microsoft Office.
- Ability to travel domestically and internationally.
- Availability to work on different Shifts as needed.
- Demonstrated interest in Medical devices, anatomy, surgery and the medical field.
- Experience with Agile/ACCS and SAP or other electronic documentation systems.
- Mid English Level (70%-80%).
**Additional Information**:
Intuitive is an Equal Employment Opportunity
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