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.)
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.
- 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.
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 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!
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:
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A choice of national medical and dental plans, and a national vision plan, including health incentive programs
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Employee assistance and family support programs, including commuter benefits and tuition reimbursement
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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
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Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
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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:
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