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QA Manager in Fremont, CA at SVS Group, Inc.

Date Posted: 10/23/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fremont, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/23/2018

Job Description

• Host and provide responses to client and ISO audits.

• Oversee Quality Management System, encompassing quality investigations including Discrepant Materials, RMA’s, Deviations, CAPAs, Training, First Article Inspections and Customer Complaints.

• Provide direction and strategy to assess and remediate, as appropriate, current, suggested and previous documentation, including conducting gap assessments, risk assessments, and development of standards.

• Review/approve deviations, CAPAs, SOPs, drawings, ISO procedures and other operations documents.

• Review and approve Risk Assessments, Process Development Reports, and Protocols.

• Quality oversight of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner.

• Quality oversight and approval of validation related documentation; this includes process, facilities, utilities, equipment, test methods, cleaning and software validations.

• Proactive identification of areas for process improvements and partnership with management to develop effective solutions that promote the company's business objectives.

• Perform analytical, statistical and trending analyses on relevant data to support timely management review and proactive response or corrective action Reviews.

• Work with Operations, Manufacturing, Engineering and Quality Control to establish, develop, communicate, and maintain a calibration plan for all company assets, including test, manufacturing, machine shop equipment and systems.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Manage the recall process including initiation, customer and regulatory notification, and product withdrawal.

• Identify and manage continuous improvement projects with the objective of achieving quality and efficiency in processes.

• Manage, develop and mentor staff.

Job Requirements

Requirements

• Bachelor’s Degree in Engineering or related field

• 8+ years in Quality Assurance in a manufacturing or medical device company

• Strong ISO 9001knowledge and in depth understanding of machined parts

• Thorough understanding of problem-solving and quality improvement tools and techniques

• Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment