- 401(k) match
- Health insurance, 100% paid for by employer including: Medical,
- Competitive vacation, sick days & paid holidays
- Tuition reimbursement
- Casual dress code
- Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.
- Monthly companywide social
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Sr. Quality Assurance Engineer - California, United States - Kinsley Power Systems
Description
Autonomous Medical Devices Incorporated (AMDI) , with its principal place of business in California, employs a world class team of engineers, scientists, clinicians, and manufacturing experts dedicated to the development and manufacture of point-of-care diagnostic devices using breakthrough microfluidics, protein engineering, and data/cloud connectivity.
Summary of Position
Title will depend on years of experience and other qualifications.
The Senior/Principal Quality & Design Control Engineer will provide 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).
He/ She will work closely with R&D, Engineering and Operations to support new product development and improve product design.He/ She will participate in development or review of requirement specifications, risk management files, planning documents, design verification and validation protocols and reports, software development and testing documentation, etc.
He/ She will ensure the design control deliverables for each design phase are completed and documented, and the Design History Files are maintained.
He/ She will participate in and support other QMS processes, e.g., conducting NCR investigations, leading CAPA processes, conducting internal audits, performing process validations.
Work under general supervision with latitude for independent judgment.Essential Duties and Responsibilities
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).
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.
Qualifications Required for Position
Bachelor's degree in engineering, science or related field required; Advanced degree preferred.
A minimum of 7 years of Quality experience in medical device industry, with at least 2 years in new product design and development.
Strong documentation skills, i.e., excellent skills in writing clear, concise and logical verification/validation/qualification protocols and reports, work instructions, and investigation reports.
Desired skills and traits
Contributes to a collaborative and inclusive work environment.
Work Environment
Work requires working at a computer station for long periods.
Will occasionally work in production and laboratory environments.
Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees including:
Company provided lunch to all employees when working at one of AMDI's on-site locations.
Vision &
Life Insurance
An Agency must obtain advance written approval from AMDI's internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts.
Our commitment to an inclusive workplace:We are an equal opportunity employer and encourage people from all backgrounds to apply.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local la w.