Job details
Salary $10 - $65 an hour job type part-time number of hires for this role 1
Qualifications
Bachelor`s (required)
Us work authorization (required)
Certified quality auditor (preferred)
Full job description
Location: remote
Project length: 6 months plus
Job description/project scope:
O leads the establishment and implementation of medical device design controls and medical device software development quality processes across multiple products.
O supports medical device new product development and design change activities ensuring execution of the quality plan, product risk management activities and other design related activities throughout the product lifecycle.
O performs design quality engineering tasks related to developing and implementing systems to ensure products are designed and produced to meet customer requirements and expectations.
O works closely with the technology team to develop and implement appropriate risk management, qualification, verification, and validation plans.
O provides technical support to engineering and regulatory team for technical files, medical devices regulation certification and declarations of conformity in support of eu product registrations/ce mark.
O provides independent oversight and review of the project deliverables throughout the product lifecycle including feasibility, development, design verification, design validation, design transfer, and commercialization reviews and activities.
O provides guidance and participates where appropriate in feasibility, development, design verification, design validation, design transfer and commercialization reviews and activities from a quality and documentation perspectiveValidates key design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs.
O performs independent technical assessment on product quality performance and post-market product quality analysis.
O uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required.
O participates in supplier quality management activities by conducting quality audits for subcontract manufacturers and critical component suppliers as requested.
O participates in quality system audits in accordance with documented procedures.
Desired qualifications:
O engineering degree or equivalent experience in medical device industry.
O at least 5-10 years` experience in design quality engineering (familiarity with the devices that have software is a plus).
O certification by asq as certified quality auditor (cqa) or quality software engineer (cqse) is preferred.
O fda/iso/ts quality system knowledge and experience necessary (any or all).
Soft skills & abilities:
O provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same.
O sound knowledge and exposure to medical device regulations (fda, mdr, mdsap etc.) and related iso/iec standards (iso 13485, iec 62304, iso 14971, etc.), related to design and development processes for standalone software medical devices.
O ability to work cross functionally to develop and maintain product device files in accordance with good documentation practices.
O excellent reporting and documentation skills.
O strong project management skills as well as an ability to multitask.
O excellent consultancy skills, a team player with the ability to connect with business stakeholders.
O be able to apply design control concepts in an agile development environment.
Job type: part-time
Pay: $10.00 - $65.00 per hour
Education:
Bachelor`s (required)
Experience:
Design quality engineering: 5 years (required)
License/certification:
Certified quality auditor (preferred)
Work location:
Fully remote
Work location: remote
