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Sr. Quality Engineer (Post Market Surveillance)

Date Posted: 6/29/2020

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Job Description

A large, global medical device company is looking to identify a Sr. PMS Quality Engineer who will be responsible for providing engineering support for EU MDR process by reviewing claims support of labeling against EU MDR regulation (SHEER & ROHS) for class I and III devices.

The individual will collaborate closely with Product Stewardship, Regulatory Affairs and across other functional teams to reconcile the bill of materials of finished good and sub-components are identified in company Hazardous Substance list. Together with product stewardship and regulatory the incumbent will be accountable for reporting relevant changes that affect the conformity the GSPR of the EU MDR or hazardous substance list to update the Technical Documentation necessary and submitted to Notified Body.

Key Responsibilities:

  • Review bill of material for disposable products identified with patient contact to analyze the presence of substance allowed by SHEER and ROHS requirements
  • Update Hazardous Substance Assessment form with material changes from bill of material
  • Understanding of CAD and product drawings/specs
  • Understanding of Bills of Material (BOMs)
  • Attention to detail, emphasis on consistency of product outputs
  • Conduct and support the Post-Market Surveillance activities to ensure compliance to EU Medical Device Regulation (MDR) requirements
  • Provide quality engineering expertise in the areas of Risk Management, Design Controls, Usability Engineering, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques, as needed
  • Highly organized and drive project plans per timeline
  • Ability to effectively analyzing data and report data with large datasets is required
  • Effective communication and presentation skills
  • Strong statistical analysis skills using excel
  • Familiarity with classification and characterization of CMR/ED substances as defined by the European Union Commission
  • Must have experience in medical device industry or working knowledge in highly FDA regulated industry

Required Skills:

  • Perform benefit/ risk assessment against substance (phthalates) material list
  • Technical Documentation- Analyze and document assessment technical reports submitted to notified body
  • Ability to effectively analyzing data and report data with large datasets is required (Excel skills- advance functions, Vlookup, macros)
  • Strong written and verbal communication skills
  • Must have Medical Device or Pharmaceutical experience
  • Eu Medical Device Regulation/ Medical Device Directive Experience preferred


Additional Skills:

  • Proven expertise in MS Office Suite and ability to operate general office machinery
  • Excellent written and verbal communication skills and interpersonal relationship skills
  • Demonstrated problem-solving, critical thinking, and investigative skills
  • Full knowledge and understanding of company policies, procedures, and guidelines relevant to quality compliance
  • Good knowledge of medical terms and human anatomy
  • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
  • Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
  • Ability to manage confidential information with discretion
  • Attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Work is performed independently on complex work and reviewed for accuracy and soundness
  • Candidate must have intermediate excel skills including: vlookpups, pivots, formulas
  • Candidate must have an understanding of statistics

Education & Experience:

  • Bachelor's Degree in Engineering or Scientific field with 4+ years' experience OR
    To apply please email your resume to sunsa@ultimatestaffing.com

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Biotech, Engineering, QA - Quality Control
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:6/29/2020
  • Contact: Sun Sa (949) 265-6070
  • Pay Range: $50.00 - $56.00 Hourly
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Job Reference: JO-2006-92841