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QA Manager

  • Location: Redwood City
  • £ Salary: Negotiable per year
  • Job Type:Permanent

Posted over 1 year ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 29 October 2022
  • Job Ref: JN -092022-474160
Quality Assurance Manager

Redwood City, CA

We are hiring for a Quality Assurance Manager to manage the Company's Quality Assurance personnel and activities including incoming QA inspection raw materials, raw material qualification program, change notification, validation, final product release, customer audit management, and various customer and internal support as required.

Responsibilities:

* Manage QA Incoming Inspection function and personnel.

* Manage product Final Release function and personnel.

* Manage raw material qualification program including maintenance of data bases and records, and change notification

* Assist with customer audit program including scheduling, pre- and post-audit activities.

* Provide customer support in areas such as completion of surveys, providing raw material information, and related QA support.

* Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits.

* Manage deviations, CAPA and associated actions and status

* Manage validations planning, coordinating, execution, completion

* Assist and support Quality Systems management in the conduct of daily operations of the department and within the Company as required.

* Trend and Analyze Quality Indicators. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.

Experience/Education:

* BS. in Microbiology/Chemistry/Biology/Chemical Engineering or equivalent experience preferred.

* A minimum of ten (10) years of Quality Assurance in medical device manufacturing or equivalent.

* Proficiency in current versions of MS Word, Excel

* Excellent communication and collaboration skills

* Good Oral and communication skills.

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