Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

What will you do?

Supports NGS Quality Systems activities including Change Control, Training, Internal Audits, Record Control, Document Control, CAPA investigations, Complaint InvestigationsEnsures the Quality System activities are in compliance with ISO 13485/MDSAP and IVDR requirements for design and development.Manages customer and Regulatory audits and inspectionsIdentifies and implements improvements to processes and systemsResponsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions at the site levelResponsible for interacting with Development personnel by facilitating meetings and discussions to communicate Quality related observations and areas for improvementWork closely supporting the R&D teams’ ability to meet quality and compliance requirements on scheduleAssist 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 standardsCollaborate with corporate partners regarding quality issues, audits, and special projects.

How will you get there?

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 PharmaceuticalPreferred:Knowledge of Quality System Management for Class I/II/III IVD devicesCertification 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 organizationProven 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!

Compensation and Benefits

The salary range estimated for this position based in California is $103,100.00–$154,700.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

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, and 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards