Quality Engineer II at Heraeus Medevio developing engineering solutions for manufacturing complaints and quality issues. Leading teams to improve product and process quality in Cartago, Costa Rica.
About the role
- Quality Engineer at Welldoc improving healthcare through software as medical devices. Supporting quality assurance and management processes in regulated medical environments.
Responsibilities
- A key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices.
- Supports Quality Assurance activities related to product development and new product introduction activities.
- Supports Quality Management System (QMS) activities including processing of controlled documents, CAPA, complaints, supplier evaluations, and training.
- Process documentation requirements in support of Welldoc’s product development process.
- Updates and maintains training and configuration of controlled documents.
- Assign training requirements as specified in the QMS for on-boarding new employees.
Requirements
- Experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc. in accordance to IEC 62304 and 21 CFR 820
- 3+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and complaints
- Experience with MDSAP, ISO 13485, ISO 14971, FDA QSR (21 CFR Part 11, 21 CFR 820), Health Canada, TGA and EU MDR
- High attention to detail and meticulous record-keeping
- Ability to work both independently and as part of a highly integrated team
- Highly proficient in multitasking and project management and organization skills
- Excellent communication and problem-solving skills
- Comfortable working in a fast-paced and agile environment
Benefits
- generous PTO
- medical insurance
- dental insurance
- vision care
- life and disability insurance
- retirement benefits
- opportunity to participate in health savings accounts and/or dependent care accounts
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