Manufacturing Quality Specialist / Pharma-Medical Device Industry

Pioneer Data Systems Inc
July 6, 2021
Milpitas, CA
Job Type


Duties & Responsibilities:

Maintains quality records on p roduct testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.

Coordinates change control documentation and approval process.

Makes proposals and assists in the development of corrective action plans and monitors implementation.

Follows up on closure of corrective and preventive actions.

Provides quality support for technology transfer and improvement of existing manufacturing processes.

Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes.

Has thorough understanding of process criteria and regulations and business impact of decisions and actions.

Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.

Prepares for and facilitates audits and inspections.

Monitors trends, identifies issues, recommends and implements appropriate actions.

Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers.


Generally Requires 4-6 Years Work Experience Education Required: University/Bachelors Degree or Equivalent

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