Quality Management System Engineer - Medical Device (Full-time/Perm)
Santa Teresa, CA, US
hace 3 días
source : PostJobFree

Quality Management System Engineer JOB SUMMARY : Quality Management System Engineer (QMSE) will play a key role in coordinating, improving, deploying and maintaining companyquality management system globally.

ESSENTIAL FUNCTIONS : Maintain and coordinate the deployment of company Quality System at the headquarters and remote offices.

Company Quality System training : schedule and provide periodic Quality System training for new employees and re-training of the existing employees.

Maintain employees training plans, training schedule and records.Document Control : maintain Quality Manual, Quality System SOPs - Work Instructions - Forms, Customer Audit and Survey records, Supplier qualifications and management records, Training Records, External and Internal Audit Records, Design History File (DHF), Device Master Record (DMR), Device History Records (DHR).

External standards : track and maintain external governing regulations, standards.Management Review : plan, coordinate objectives matrix collection and presentation.

  • Corrective and Preventive Actions : monitor and coordinate CAR, PAR, SCAR review meetings, create CAR, PAR, SCAR trending monthly reports;
  • work with cross-functional team and / or suppliers in CAR investigation and root cause analysis; develop corrective actions for reported quality issues with effectiveness measurement.

    Complaints and MDR evaluations : monitor and maintain Complaint and MDR evaluation records.External audits : coordinate documents / records preparation to ensure timely response to documents requested from auditors and respond timely to audit findings.

    Internal, Supplier audits : facilitate audits schedule, perform audits and identify improvement opportunities.Statistical process control : analyze Quality System objectives data to evaluate effectiveness of company quality management system.

    Nonconforming material (NCR) : facilitate and monitor Material Review Board (MRB) activities.Perform other essential duties as directed.

    EDUCATION / EXPERIENCE : Bachelor's Degree in Engineering (Biomedical, BioTech, Electrical, Computer or Industrial Engineering).

    3-5 years of experience in Medical Device Quality Management System required.Quality System development, deployment, training, internal audit, document control, supplier management and development.

    Working experience with medical device regulations (FDA 21 CFR 11, 820), international regulations and standards (MDD, ISO 9001 : 2008, 13485 : 2003, 14971 : 2007) required.

    Experience in using ERP, Quality System Management.Must have ISO certification for 9001 : 2008, 13485 : 2003, 14971 : 2007 Lead Auditor, CQA.

    ADDITIONAL SKILLS AND KNOWLEDGE : Strong written and presentation skills; ability to read and interpret applicable FDA regulations, ISO standards, Quality System documents.

    Proficiency in MS Office 2007; Word, Excel, Publisher, Visio, etc.Familiar with non-compliance trending statistic analysis methodology and tools.

    Ability to work independently and in a team environment and manage multiple tasks effectively in a very fast paced work environment.

    Ability to lift up to 60 lbs; and stand, walk, and sit for extended period of time.Occasional travel may be required.No sponsorship visa (H1-B, etc) candidates at this time, sorry.

    Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to : COYOTE TECHNICAL & EXECUTIVE SOURCING Phil Montoya Director of Sourcing 220 Miracle Mile, Suite B219 Coral Gables, FL 33134 P : Fax : Like us on Facebook Link up on LinkedIn Follow us on Twitter For more job openings, please visit

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