Staff QA Engineer

at  Thermo Fisher Scientific

JOB DESCRIPTION

The Quality Assurance Staff Engineer role helps the Thermo Fisher Scientific mission by ensuring that the Next Generation Sequencing (NGS) labs, housed within the Carlsbad, California site, are meeting the requirements of the Quality Management System established and maintained at the Frederick Maryland facility. You will do this by providing support, training, guidance/mentorship, and leadership to the Development team to ensure quality and regulatory requirements are achieved and maintained. You will be viewed as the NGS lab Quality “go-to” individual providing complete quality support helping to maintain an environment that meets all applicable ISO 13485/MDSAP and IVDR requirements for design and development.

EDUCATION

• Bachelor’s degree in a STEM (science, technology, engineering, or math) subject area required

EXPERIENCE

• Minimum of 3+ years related experience in Medical Device or Pharmaceutical
• Preferred:
• Knowledge of Quality System Management for Class I/II/III IVD devices
• Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr)
• Experience with Trackwise, Agile, E1/SAP is a plus

INDUSTRY KNOWLEDGE, SKILLS, ABILITIES

• Knowledge of International Standards, ISO-13485, MDSAP, IVDR and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
• Site specific software programs (change control notification program), CAPA (Trackwise preferred, etc.).
• Strong verbal and written communication skills.
• Confidence addressing multiple levels within the organization
• Proven track record using Microsoft Suite applications (Outlook, Word, Excel, PowerPoint)
• Ability to work efficiently within a team in a fast-paced changing environment.
• Ability to act quickly and conclusively!

• Supports NGS Quality Systems activities including Change Control, Training, Internal Audits, Record Control, Document Control, CAPA investigations, Complaint Investigations
• Ensures the Quality System activities are in compliance with ISO 13485/MDSAP and IVDR requirements for design and development.
• Manages customer and Regulatory audits and inspections
• Identifies and implements improvements to processes and systems
• Responsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions at the site level
• Responsible for interacting with Development personnel by facilitating meetings and discussions to communicate Quality related observations and areas for improvement
• Work closely supporting the R&D teams’ ability to meet quality and compliance requirements on schedule
• Assist in preparation and/or review documentation required for regulatory submissions.
• Ensure all required compliance documentation is current and available upon request.
• Maintain awareness of applicable standards and regulations, by leading activities related these standards
• Collaborate with corporate partners regarding quality issues, audits, and special projects.