Quality Control Technician Documentation

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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 minimally invasive care. Job Description

Primary function of the position:

The Quality Control Technician Documentation is responsible for reviewing device history records (DHRs) for accuracy and completeness, ensuring compliance to product specification and traceability requirements and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments

Roles and Responsibilities:

• Reviews DHRs in SAP for compliance to product specifications and company traceability requirements, authorizing release of product for distribution to customers and New Product Introduction (NPI) launches
• Recording of defects and coordination of the rework of rejected products with the responsible departments
• Blocking and releasing of products and initiation of necessary corrective actions incl. effectiveness testing in coordination with the responsible persons
• Ensures that any non-conformances or deviations are properly approved and documented in the DHR
• Performs SAP transactions and ensures that released products are transacted in a timely manner
• Works collaboratively with internal customers to resolve DHR issues in a timely manner
• Regular communication exchange with related departments and represents the team in cross-functional meetings
• Participation in the preparation of statistics and (test) instructions, generates data used for monitoring as directed by management
• Participates in projects or other activities as directed by management
• Compliance with the current QMS, DOPs and SOPs and the safety regulations
• Perform other duties as assigned.
• Overall coordination, tracking and status of all internal non-conforming materials (NCRB)
• Interface between various departments to clarify the status of open quality notifications (NCRs) and close these QNs.
• Monitor quality notifications (NCRs) so that they are processed in a timely manner, following, and adhering to QMS Documents
• Processing of dispositioned material - scrapping of parts from NCRs
• Generates information on non-conformance data and prepares reports.
• Controls and monitors postings/retirements within the NCRB in the system and physically

Qualifications

Required Knowledge, Skills and Experience:

• Hands-on technician with at least 3 year of related operational experience in a Product Quality or certified (e.g. FDA, ISO, Mil-Spec, etc.) manufacturing environment or applicable
• a recognized commercial or technical training occupation under the Vocational Training Act (BBiG) with at least 2 year of related operational experience in a Product Quality or certified (e.g. FDA, ISO, Mil-Spec, etc.) manufacturing environment
• Proficient communication and documentation skills in Bulgarien and English
• Proficient computer experience including MS Office products and ERP systems (preferably SAP)
• You work in an organized and methodical manner, have a high implementation orientation as well as a pronounced awareness of quality and quality processes
• Even with an increased workload, you work in a structured, thorough and independent manner
• You enjoy working in a cross-functional team
• Very good interpersonal skills
• Proficient analytical, problem-solving, and root-cause analysis skills
• Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift: Day
Travel: None