November 15, 2021

Quality Systems Engineer/Associate (Document Management, CAPA Management, Training)

Pasadena
Posted 3 weeks ago

Innova Medical Group, Inc. delivers better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious diseases. In response to the global pandemic, Innova developed an end-to-end ecosystem of rapid diagnostic and screening tests, along with digital reporting and tracing applications to help organizations manage the COVID-19 crisis. In 2020, Innova delivered more than 220+ million COVID-19 test kits to over 20 countries around the globe, including the United Kingdom, Hungary, Singapore, United Arab Emirates, and Myanmar. As a leader in the research and development of in-vitro diagnostic reagents and test kits, Innova​ has improved lives with testing, monitoring, and implementing medical care. Innova Medical Group is a wholly owned subsidiary of Pasaca Capital, Inc. and is headquartered in Pasadena, CA.

Job Description
The Quality Systems Engineer/Associate is responsible for Quality Management System compliance including Document Management, CAPA Management and Training Systems Management, related to maintence of QMS processes for medical device and in-vitro diagnostic products. The position is responsible for establishing and maintaining and improving the Innova quality management system to ensure compliance to ISO 13485, 21 CFR 820 and other applicable regulations.
Responsibilities (Specific tasks, duties, essential functions of the job)

  • Maintain an effective Quality Management System in compliance with global regulatory requirements including but not limited to ISO 13485:2016, MDSAP, National Medical Products Administration (NMPA) in China, and other international markets as determined by business objectives.
  • Oversee all functional areas of the QMS including:
    • Personnel Training, Qualification and Competency
    • Document and Record Controls
    • Product Identification and Traceability
    • Corrective and Preventive Action
    • Analysis of Data and Statistical Techniques
  • Maintain a program for internal Quality System training and provision of annual GMP training.
  • Ensure standardization exists between operations in all facilities for Document Management, CAPA and Training Systems.
  • Comply with all company policies and procedures.
  • Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

  • Must have a broad background of QMS activities in all Document Management, CAPA and Training
  • Capable of compiling data from various sources to produce useful reports and capable of trending and verifying process improvements.
  • Excellent management skills, for projects.
  • Must have strong work ethic.
  • Excellent oral and written communication skills required.
  • Attention to detail is required.
  • Effective conflict resolution.
  • Analytical & problem-solving skills & ability to multi task.
  • Solutions-oriented problem solver.
  • Excellent planning, communication and organizational skills.
  • Ability to effectively interface with different departments within the company.
  • Specific functional knowledge of global regulatory requirements, directives, and standards such as EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP and NMPA programs and a track record of successfully maintaining these programs globally.
  • Able to show flexibility in approach depending on the business need.

Qualifications

  • Bachelor’s degree in Engineering, Biological Science or related technical discipline, or equivalent experience.
  • 5+ years’ experience in Quality for a medical device or in-vitro diagnostic company, required.
  • Direct experience in Quality Systems preferred.
  • Advanced knowledge/proficiency in Microsoft Office, required.
  • Familiarity with Trackwise QMS system preferred.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Legal authorization to work in the United States is required.
This job may be subject to a background check, consistent with State and local law, including where applicable the Los Angeles Fair Chance Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act.

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