Job details

Description

The Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities. Additionally, this position will operate as a liaison among the various R&D functions and the Quality Operations departments.

Essential Duties and Responsibilities

• R&D Project Teams:
  • Responsible for supporting Medical Devices Project Teams and attending meeting in a Quality consultancy capacity
  • Support document reviews and regulatory submissions
  • Effectively manage project timelines as defined by department, project team, and corporate objectives
• Risk Management:
  • Facilitate and provide input to risk management activities throughout all stages of the device development process
  • Manage the risk management plan, risk file and risk report for assigned projects
• Human Factors Engineering:
  • Facilitate and provide input to human factors/usability activities throughout all stages of the device development process
  • Manage the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report
• Design & Development:
  • Facilitate and provide input to Medical Device manufacturing and Design & Development activities throughout all stages of the device development process (e.g. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control).
  • Provide input and review Design & Development documentation for  assigned projects
• Audits:
  • Conduct R&D related audits, both internal and external
  • Support R&D vendors/suppliers qualifications
  • Support all Merz regulatory authority inspections and certification body audits, as applicable 
• General R&D Support:
  • Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives
• R&D Quality Improvements:
  • Facilitate and support harmonization initiatives within the R&D group
  • Facilitate and support projects to improve R&D compliance and operational efficiencies
• Quality Intelligence:
  • Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant as related to Medical Devices
  • Provide updates to R&D staff, as applicable 
• Further Tasks:
  • Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate
  • Provide support to other R&D staff as needed and perform duties and assignments as required
• Other duties as assigned:
  • Additional duties as needed to support the business and overall company objectives 

Job Related Qualifications/Skills

Professional Experience

• Required:
  • Minimum 2 years relevant Quality/Compliance and medical device development experience
• Preferred:
  • Certification(s) – ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality Auditor
  • Energy-Based Device Experience

Knowledge, Skills and Abilities

• Required:
  • Proficient in all MS Office applications
  • Demonstrated organizational skills, ability to independently prioritize work and detail oriented
  • Strong verbal and written communication skills
  • Ability to effectively multitask and manage multiple projects
  • Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred
  • Knowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines.)
  • Ability to work effectively in a global, matrix environment
• Preferred:
  • Ability to travel up to 15%

Education

• Required:
  • Bachelor’s Degree in Engineering or Life/Health Sciences
• Preferred:
  • Master’s Degree

Behaviours

Motivation

Education

Experience

Licences & certifications