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About the role
- Quality Engineer managing QA processes for a medical device company developing software as medical devices. Ensuring compliance and leading quality initiatives across engineering and clinical teams.
Responsibilities
- Manages and supports Controlled Documents on Welldoc’s electronic QMS (eQMS) and Learning Management System (LMS).
- Play the role of a Quality Lead on product development core teams to advocate QMS requirements and to provide guidance to the project team.
- Provide, improve, and maintain quality methodologies, processes, and procedures.
- Support continuous improvement initiatives and projects to improve processes and upgrade Welldoc’ s QMS.
- Establish and maintain effective cross-functional team communications to advance quality.
- Proactively provide inputs to develop a master plan for Welldoc’ s for our quality initiatives and objectives.
- Improving key aspects of our quality systems as part of daily tasks.
- Contribute to QMS management reviews in a timely and effective manner.
- Interface with Quality Assurance / Quality System peers in external partner organizations.
- Manage and support internal and external audits and inspections, ensuring compliance with regulations.
- Partner with R&D, Engineering, Clinical, etc., in the development of new products.
- Maintain and update training programs and manage the configuration of controlled documents.
Requirements
- 5+ years’ experience with FDA and ISO 13485 regulated medical device product development
- Practical knowledge or experience with design controls, production, and process controls, CAPA, complaint handling, and post-market / vigilance requirements
- Experience with MDSAP, ISO 13485, ISO 14971, 21 CFR 820, FDA QSR, Health Canada, TGA, and EU MDR.
- Ability to author, review, and update technical or QMS documents.
- Experience with software verification, validation, and software hazards analysis.
- Experience or practical knowledge of IEC 62304 and agile methodologies is preferred.
- Experience with software quality and software as a Medical Device (SaMD) is a plus
- Attention to detail and meticulous record-keeping.
- Ability to work both independently and as part of a highly integrated team.
- Multitasking and project organization skills are a must
- Excellent communication and problem-solving skills
- Comfortable working in a fast-paced and agile environment with distributed teams across different time zones
Benefits
- generous PTO
- medical insurance
- opportunities for employee development and advancement
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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