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Full Time Fmea Jobs (NOW HIRING)

AMBE Engineering LLC

Quality Engineer

MS · On-site

$66K - $85K/yr

Quality Engineer Full-Time Water Valley, MS The Quality Engineer is responsible for supporting ... Support new product development, launches, and product/process changes using APQP, PPAP, FMEA ...

Cimarron

Reliability Engineer

Houston, TX · On-site

$100K - $150K/yr

... Type Full-time # of Hires Needed 1 Education Bachelor's Degree Travel None Security Clearance ... Describe the worst-case failure effects for each failure mode in FMEA. * Include an assessment of ...

Prysmian Group

Engineering Intern

Jackson, TN · On-site

$16 - $20.75/hr

Make Your Mark at Prysmian Group - Join Us Summer Intern - Full Time About the Role We're seeking a ... FMEA Development * Participate in or facilitate FMEA sessions for priority processes/equipment.

PrysmianGroup

Engineering Intern

Jackson, TN · On-site

$16 - $20.75/hr

Make Your Mark at Prysmian Group - Join Us Summer Intern - Full Time About the Role We're seeking a ... FMEA Development * Participate in or facilitate FMEA sessions for priority processes/equipment.

TiltEdge Solutions LLC

ECU Lead Architect

Auburn Hills, MI · On-site

$52.25 - $71.75/hr

Fulltime Position Context The ECU Lead Architect is the technical authority responsible for the end ... Technical Support to FMEA activities, including Hardware FMEA, Software FMEA, and Safety Mechanism ...

Yinlun TDI LLC

Quality Engineer

Houston, TX · On-site

$68K - $88K/yr

Job Type Full-time Description This position is established to ensure product and process quality ... Responsible for quality planning during new product development (APQP, PPAP, FMEA, Control Plan ...

PSG

QUALITY ENGINEER - Hot Job

Spartanburg, SC · On-site

$70K - $85K/yr

Performs quality planning in assigned production area utilizing FMEA and Control Plan tools ... Ability to manage cross-functional teams to resolve problems Job Type: Full-time Pay: $70,000.00 ...

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Full Time Fmea information

What is the difference between Full Time Fmea vs Full Time Fmea?

AspectFull Time FmeaFull Time Fmea
CredentialsRelevant certifications in quality, risk management, or engineeringSame as Full Time Fmea
Work EnvironmentManufacturing, automotive, aerospace, or industrial settingsSame as Full Time Fmea
Employer & IndustryCompanies focusing on quality assurance, risk analysis, and process improvementSame as Full Time Fmea
Comparison FocusUnderstanding roles and responsibilities of a Full Time FmeaSame as Full Time Fmea

Since the comparison is between the same job title, Full Time Fmea, the key differences often relate to specific industry applications or employer expectations rather than job title distinctions. Full Time Fmea roles typically involve risk assessment and quality management in manufacturing or engineering sectors, emphasizing certifications and industry standards.

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Full Time Fmea jobs near you

Senior Aseptic Processing & Contamination Control Consultant (FT, Contract)

Baltimore, MD • On-site

Workforce Genetics
See more jobs at Workforce Geneticsexternal

$91K - $115K/yr

Full-time

Posted 22 days ago

Job description

Our client is hiring a Senior Aseptic Processing & Contamination Control Consultant to provide technical leadership for a 2-month (approx. 12-week) full-time contract project addressing FDA 483 audit findings. In this role, you will perform a thorough review and risk assessment of legacy aseptic fill-finish processes (focusing on non-isolator, manual assembly environments and first air challenges). You will facilitate risk assessment workshops and guide the execution of FMEA models across 100+ high-risk manual interventions to identify contamination mechanisms and drive risk reduction strategies via the eliminate-replace-reduce-control engineering hierarchy in support of CAPA-102537, CAPA-102539, and ICP-100445.


Experience:

  • 15+ years of sterile manufacturing and legacy aseptic systems experience (manual assembly, open RABS/laminar flow environments)
  • Deep aseptic processing expertise and FMEA risk profile model execution
  • First air principles specialist
  • Contamination control expert
  • Strong documentation skills
  • Aseptic risk assessment workshop facilitation
  • Application of eliminate-replace-reduce-control risk reduction hierarchy


Day-to-Day Responsibilities:

  • Facilitate risk assessment workshops to map detailed step-by-step process executions (e.g., ~25-step manual interventions) in legacy, non-isolator aseptic systems.
  • Identify specific contamination mechanisms and first air disruption risks across legacy manual assembly environments.
  • Perform Failure Mode and Effects Analysis (FMEA) to calculate Risk Priority Numbers (RPN) and quantify risk drivers for high-risk interventions.
  • Drive risk reduction strategies using the eliminate-replace-reduce-control engineering hierarchy to establish interim and long-term mitigations.


The company provides sterile injectables and offers clinical and commercial non-viral aseptic fill/finish services for vials and pre-filled syringes on four fill lines, in addition to lyophilization, terminal sterilization, analytical, stability, packaging and serialization, and additional support services.