Product Release Associate
Product Release Associate
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Job Description
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:
- Minimum of 5 years ofrelated experience with a Bachelors
- University degree or 3 years experience and aMasters degree
- Technical education Bachelors degree
- Proficient communication and documentation skills in English
- Proficient computer experience including MS Office products and ERP systems (preferably SAP)
- nalytical 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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
