Primary Location: United States-North Carolina-Durham-US-NC-Durham
Requisition ID: 200756
Primary function of position
The Quality Assurance (QA) Associate is responsible for reviewing device history records (DHRs) for accuracy and completeness, certifying 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.
The QA Associate receives guidance on workload prioritization from the team lead, but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support.
- Product Release
- Reviews DHRs for da Vinci systems, instruments, and accessories for compliance to product specifications and company traceability requirements, creating certification documents and authorizing release of product for distribution to customers and New Product Introduction (NPI) launches
- Reviews and approves records from sterilization sub-contractors to assure sterility of single-use products
- Ensures that any non-conformances or deviations are properly approved and documented in the DHR
- Works collaboratively with internal customers to resolve DHR issues in a timely manner
- Reports on workload status regularly within the team and identifies issues which pose a potential risk to team goals
- Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations
- Participates in department process improvement projects or other activities as directed by management
Critical Competencies for Success
- Team-Oriented: Approaches their work selflessly and without ego, making an honest effort to manage their own assigned workload, communicating openly and in a timely manner when deliverables are at risk, and actively seeking opportunities to ask “How can I help?” Freely shares information and makes it a priority to mentor their peers when the opportunity presents itself.
- Quick Study & Continuous Learner: Demonstrates aptitude for learning new processes quickly, actively seeks deeper understanding of processes and functions critical to their role. Strives to understand the bigger picture and how their role supports key company objectives.
- Perceptive & Detail Oriented: Skilled at sensing variations from the norm and thoroughly investigating whether compliance to company process has been maintained. Demonstrates ability to execute competently and consistently to fundamental job skills while advancing knowledge in more complex disciplines.
- Initiative & Follow-through: Seeks opportunities to improve departmental process and expand personal contributions. Can be relied upon to complete commitments without excessive follow-up.
- Good Judgment: Strong ability to draw correlations to prior experience and identify precedent in ambiguous circumstances. Demonstrated track record of making good decisions.
- Ethical & Independent: Demonstrates recognition of the criticality of the job function and strives to conduct themselves in a manner which does not invite doubt about their ability to consistently execute process without direct supervision. Does not cut corners or bow to external pressure to compromise on requirements.
- Effective Communicator: Excellent verbal and written communication skills. Skilled at making use of visual aides to convey complex concepts to diverse audiences.
- 2+ years of operational experience in a Product Quality or certified (e.g. FDA, ISO, Mil-Spec, etc.) manufacturing environment
- Exceptional analytical, problem-solving, and root-cause analysis skills
- Excellent verbal and written communication
- General familiarity with spreadsheet, word processing, and email software
- Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.