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

Why apply through Brunel? Finding the next step in your career can be a fulltime job. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

Join the Brunel Family

Career interview session

Join the Brunel Family

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Application process

1

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.

2

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.

3

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

4

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.

5

Submission of candidates resume for client’s approval and screening.

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

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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