Product Release Associate
Product Release Associate
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Job Description
Primary function of the position:
The Product Release Associate (gn) 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 nonconformances 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 crossfunctional 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.
Qualifications :
Required Knowledge Skills and Experience:
- Handson technician with at least 3 years of related operational experience in a Product Quality or certified (e.g. FDA ISO MilSpec etc.) manufacturing environment or applicable.
- A recognized commercial or technical training occupation under the Vocational Training Act (BBiG) with at least 2 years of related operational experience in a Product Quality or certified (e.g. FDA ISO MilSpec etc.) manufacturing environment.
- Proficient communication and documentation skills in Bulgarian 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 crossfunctional team.
- Very good interpersonal skills.
- Proficient analytical problemsolving and rootcause 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
