Sr Quality Assurance Engineer

Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Each of AMDI’s Autolabs are small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver secure lab quality results in <15 minutes. AMDI has built a world class, multi-disciplinary team of engineers, scientists, clinicians, and database experts and will launch its first Research Use Only (RUO) products in 2023 from its ISO 13485 certified 110,000 square foot facility in Santa Ana, CA.

Summary of Position

The Senior Quality Assurance (QA) 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). 
  •    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.

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. 
  •    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.

Desired skills and traits

•      Contributes to a collaborative and inclusive work environment.
  •    Results oriented – drives progress & excellence.
  •    Someone who has high standards, takes ownership, and is invested in the outcome.
  •    Someone who proactively helps others and stays positive.
  •    Experience with software development and software V&V activities, and mastery knowledge of ISO, IEC and FDA requirements for software. 
  •    IVD medical device experience preferred.
  •    Quality engineering certification (ASQ CQE or CQA) desired.

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.

- 401(k) match

- Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance

- 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 company-wide social

Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. 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 law.