LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Learn more in our Cookie Policy.
Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings.
This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.
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 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.
How will you get there?
Education
Bachelors degree or equivalent related experience.
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.
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, and 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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Biotechnology
Referrals increase your chances of interviewing at myGwork - LGBTQ+ Business Community by 2x