Staff QA Engineer

$103,100 - $154,700/Yr

Thermo Fisher Scientific - Carlsbad, CA

Full-time - Mid Level

Carlsbad, CA

Computer and Electronic Product Manufacturing

About the position

The Quality Assurance Staff Engineer role at Thermo Fisher Scientific is pivotal in ensuring that the Next Generation Sequencing (NGS) labs at the Carlsbad, California site adhere to the stringent requirements of the Quality Management System established at the Frederick Maryland facility. This position is integral to the company's mission, providing essential support, training, guidance, and mentorship to the Development team to ensure that quality and regulatory requirements are consistently met and maintained. As the go-to individual for NGS lab quality, you will play a crucial role in maintaining an environment that complies with all applicable ISO 13485/MDSAP and IVDR requirements for design and development. In this role, you will support various NGS Quality Systems activities, including Change Control, Training, Internal Audits, Record Control, Document Control, CAPA investigations, and Complaint Investigations. You will ensure that all Quality System activities comply with ISO 13485/MDSAP and IVDR requirements, leading customer and regulatory audits and inspections. Your responsibilities will also include identifying and implementing improvements to processes and systems, collecting data, and performing statistical analyses to investigate trends and provide interpretations at the site level. You will interact closely with Development personnel, facilitating meetings and discussions to communicate quality-related observations and areas for improvement. Additionally, you will assist in the preparation and review of documentation required for regulatory submissions, ensuring that all compliance documentation is current and readily available. Maintaining awareness of applicable standards and regulations will be essential, as will collaborating with corporate partners on quality issues, audits, and special projects.

Responsibilities

• 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
• Leads customer and Regulatory audits and inspections
• Identifies and implements improvements to processes and systems
• Responsible for collecting data, performing moderately sophisticated 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

Requirements

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

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO)
• 10 paid holidays annually
• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
• Accident and life insurance
• Short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount