Quality Specialist- Medical device

1 month ago


Fremont, United States Intelliswift Software Full time

Job Description:


Key Responsibilities:

The position may also be called upon to participate in other Quality System initiatives, such as working within the CAPA subsystem (SCAR, Complaint, CAPA, Non-conformance), design controls, risk management, or other areas within the Quality Assurance function..


• Gather, analyze and document product formulas for use in the creation of Safety Data Sheets

• Ownership of activities that lead to improvement in Quality metrics

• Investigate and drive customer complaints related to product labeling to closure in a timely manner

• Support NC and CAPA process and NC and CAPA investigations

• Communicate with internal stakeholders to prioritize and complete requests to meet customer expectation

• Work with cross-functional teams (e.g.: R&D, Operations, Manufacturing Engineering, Service and Support, Product Management, Business Development, QA, QC, Regulatory Affairs) to drive resolution for internal issues/projects

• Supports completion and execution of Engineering Change Orders (ECOs) and Product/Process Change Orders (MOCs)

• Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.

• Calculate Failure/Harm occurrence rankings based on field data as required

• Provide input, feedback and data for Quality report outs, Management Review, etc.

• Support internal and external audits (FDA, ISO, MDSAP etc.)


Minimum Requirements/Qualifications:

• Minimum BS/BA in scientific discipline (preferably chemistry or chemical engineering) with 2-5 years related experience

• Experience in a regulated industry (medical device, in vitro diagnostics preferred)

• Experience and knowledge of investigation techniques and related tools: 8D, Root Cause Analysis, etc

• Strong organizational skills and attention to detail

• Must be able to write clear, understandable documentation

• High level of verbal communication skills

• Ability to manage multiple tasks simultaneously

• Ability to work independently

• Ability to perform simple data analysis and to summarize results

• The following experiences/skill sets are highly desirable: ISO 13485, ISO 14971, statistical techniques.


Exact Shift: M-F 8am-5pm



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