QMS Manager/ Engineer

PUB315173

About this role

About this role

We are currently hiring a QMS Manager/ Engineer for our client who is a global medical aesthetic technology leader. This role will report directly to the Senior Manager, Quality and be based in San Jose, California. The successful candidate will be responsible for maintaining the Quality Management System (QMS), writing procedures and processes to support QMS development. Additional responsibilities will include leading and undertaking audits across all areas of the business and across every stage of the supply chain.

Responsibilities

  • Support the implementation of new processes and procedures, including the selection and implementation of a new electronic QMS and maintenance all QMS content and master files.
  • Assist and ensure the Quality Management System and regulatory compliance requirements are effectively maintained, implemented, and monitored.
  • Monitor quality issues, identify actions needed to correct, inform management of any issues and drive corrections.
  • Identify gaps, enhancements and create/establish process checklists/forms, work instructions, non-conformance reports and ensure all quality check procedures are put in place.
  • Monitor compliance with standard operating procedures and ISO/QSR requirements.
  • Provide continuous assessment of the Quality Management System including CAPA, internal audit, management reviews and other related processes to ensure compliance.
  • Administer the Corrective and Preventive Action Systems for customer feedback, supplier conformance and internal continuous improvement projects.

Requirements

Requirements

Requirements

  • BS Engineering (preferred) or related technical area.
  • 2-5 years of Quality Systems or Engineering experience. Process management experience required.
  • 2-5 years of experience with Quality Systems regulations including 21 CFR 820 and ISO 13485.
  • High level of experience and understanding of GMP/GLP system requirements.
  • Experience with the execution of quality systems like CAPA, NCMR, deviations and document control.
  • Certified Internal Auditor (preferred) and experience in medical devices is an asset.
  • Excellent skills in organization, record keeping and oral and written communications.
  • Ability to collaborate cross functionally and work in a team dynamic.
  • Proactive, self-motivated mindset.

Benefits

Benefits

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Any questions remaining?

Your consultant, Chris Kapusta is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB315173

Account manager

Chris Kapusta
Brunel Canada - Calgary
c.kapusta@brunel.net

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