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Company

Original Job Post

Thermo Fisher Scientific · 1 day ago

Staff QA Engineer

Carlsbad, CA

Full-time

Onsite

Mid Level

$103K/yr - $155K/yr

3+ years exp

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BioinformaticsBiotechnology

H1B Sponsorship

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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.

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical devicePharmaceuticalInternational standardsISO-13485MDSAPIVDR21 CFR Part 820FDA QSRMicrosoft SuiteCommunicationTeamworkProblem-solvingQuality System ManagementIVD devicesASQ CertificationTrackwiseAgileE1/SAPSite-specific software programsChange control notification programCAPAConfidence addressing multiple levels

Required

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

Minimum of 3+ years related experience in Medical Device or Pharmaceutical

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

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!

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

Experience with site-specific software programs (change control notification program), CAPA (Trackwise preferred, etc.)

Confidence addressing multiple levels within the organization

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, 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

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)