- Provides QA guidance and support throughout the entire design control and product realization processes to ensure that medical device/products meet all applicable regulations and standards (e.g., ISO13485 requirements, 21 CFR Part 820, other applicable FDA regulations and guidance documents, applicable ISO and IEC standards, and regulations of applicable global regulatory authorities).
- Works closely with R&D, Engineering and Operations to support new product development and improve product design.
- Leads risk management activities, e.g., creating or reviewing risk management plans, risk assessment documents and risk management reports.
- Writes, or reviews validation protocols and reports. Work with supplier quality and supply chain groups to ensure product suppliers are effectively developed.
- Verifies configuration management and Risk Analysis records are properly addressed, accurate, and maintained.
- Supports software development activities to ensure compliance with applicable regulations and standards.
- Leads design transfer activities pertaining to product quality and regulatory compliance.
- Ensures design changes are processed in accordance with current change control requirements.
- Participates in and support other QMS processes, e.g., conducting NCR investigations, leading CAPA processes, conducting internal audits, performing process validations.
- Completes assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for product development activities.
- Coordinates resolution of potential quality assurance deficiencies discovered during the product realization process.
- Additional projects and/or duties as assigned.
- Bachelor's degree in engineering, science or related field required; Advanced degree preferred.
- 7+ years of Quality experience in medical device industry, with at least 2 years in new product design and development.
- Hand-on experience with design control processes, and mastery knowledge of ISO 13485:2016 and 21 CFR Part 820.
- Hand-on experience with risk management and mastery knowledge of ISO 14971.
- Well organized and attentive to detail.
- Strong documentation skills, i.e., excellent skills in writing clear, concise and logical verification/validation/qualification protocols and reports, work instructions, and investigation reports.
- Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within colleagues and suppliers
- Ability to interpret trends and data, translating the information into actions and improvements.
- Strong verbal and written communication skills.
- Proficient with QMS software. Tech-savvy and able to learn new software easily.
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