- 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
- 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
- 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%
- Required:
- Bachelor's Degree in Engineering or Life/Health Sciences
- Preferred:
- Master's Degree
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Quality Engineer - Raleigh, United States - Merz Pharmaceuticals LLC
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.
Essential Duties and Responsibilities
Professional Experience
