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.
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
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
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 email@example.com
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