Engineer II, QA - Miami, FL

Thermo Fisher Scientific Inc

Miami, FL

JOB DETAILS
SKILLS
American Society for Quality (ASQ), Analysis Skills, Auditing, Biology, Biotech and Pharmaceutical, Cancer, Certified Quality Engineer (CQE), Change Control, Chemistry, Cleanroom, Code of Federal Regulations, Communication Skills, Consensus Building Skills, Continuous Improvement, Control Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Establish Priorities, External Audit, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), ISO 9001, Internal Audit, Lead Generation, Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Equipment, Microsoft Office, Patient Care, Performance Metrics, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Productivity Management, Project/Program Management, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Requirements, Resolve Customer Issues, Risk Analysis, Risk Management, Root Cause Analysis, SAP, Safety Standards, Standard Operating Procedures (SOP), Statistics, Strategic Planning, Technical Writing, Test Plan/Schedule, Writing Skills
LOCATION
Miami, FL
POSTED
30+ days ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

Performs statistical analysis and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support site level performance to KPIs (e.g. yield improvements, CAPA, complaint and scrap reduction). Those activities include the planning, development and support of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements

REQUIREMENTS:

  • Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology
  • Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field
  • ISO 13485/FDA Lead Auditor certification beneficial
  • ASQ certification (CQE, CQA) advantageous
  • Strong knowledge of quality systems, cGMP regulations, and standards including ISO 9001:2015, 21 CFR Part 820, 21 CFR Part 211
  • Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and change control
  • Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
  • Excellent documentation and technical writing skills for developing SOPs, protocols and reports
  • Strong proficiency in quality management software (TrackWise, SAP QM, etc.) and Microsoft Office suite
  • Experience conducting internal audits and supporting external regulatory inspections
  • Demonstrated ability to build consensus and collaborate across functions
  • Strong verbal and written communication skills
  • Ability to work independently while contributing effectively in team environments
  • Strong attention to detail with analytical and problem-solving capabilities
  • Experience with statistical analysis tools and quality metrics reporting
  • Project management skills and ability to prioritize effectively
  • Ability to work in clean room environments when required
  • Designee for QE Manager as required including attending meetings, participating in customer audits, represent QE team at technical visits and on customer calls.
  • Strategically planning across the network supporting AQP establishment/strengthening the QE teams as one global network teams.
  • Support the site change control system including process risk assessment in the form of FMEA tools.
  • Works directly with customers on complex critical quality issues/complaints. Leads issue/complaint resolution.

About the Company

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Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html