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GForce Life Sciences
Palm Beach Gardens, FL | Contractor
6 Months Ago
Quality Engineer
GForce Life Sciences Palm Beach Gardens, FL
Contractor | Business Services 6 Months Ago
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GForce Life Sciences is Hiring a Quality Engineer Near Palm Beach Gardens, FL

Consultant, Quality Engineer, Validation, Medical Devices 

Summary 

Our client, a rapidly growing medical device firm, requires a quality engineer to join their team to perform validations and qualifications of new/existing equipment and processes in a medical device environment. Focus on validations will be to document the processes and equipment to current regulatory standards and requirements. 

Duties / Expectations of Role 

  • Will provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls. 
  • Communicates current and applicable good manufacturing practices (GMP) and good laboratory practices (GLP) (e.g.: ISO13485 / 21 CFR Part 820 / CMDR) to business partners. 
  • Executes functions needed to support change control activities and document management requirements. 
  • Collaborates with business partners and peers to define validation and change control activity requirements for individual projects. 
  • Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on. 
  • Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability / reliability. 
  • Leads / participates in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA). 
  • Writes/revises or reviews /approves a variety of validation lifecycle documents. 
  • Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports. 
  • Supports the delivery of system solutions by assuring validation activities are conducted in a compliant but cost effective manner. 
  • Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations. 
  • Performs investigations and troubleshoots validation problems for equipment, performance process and system and so on. 
  • Audits the compliance of validation activities and assists during internal / external audits. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities. 
  • Proactively identifies and resolves issues, and escalates concerns as appropriate. 
  • Ensures corrective actions are completed in a timely manner. 
  • Promotes continuous improvement by ensuring adherence to quality principles. 
  • Seeks out and actively participates in business initiatives that contribute to service excellence. Collaborates and teams with Laboratory, Quality and Validation Engineering, LIMS, and project management personnel. 

Mandatory Requirements 

  • Bachelor of Science in Engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE). 
  • 5 years of experience in Quality within a medical device organization.
  • A strong background in validation (and statistical tools such as Sampling Plans, Experimental Design and Optimization) is required. 
  • Knowledge of current and applicable GMP regulations is required. 
  • Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required. 
  • Experience in Supplier Quality

Nice to Have Requirements 

  • Validation experience is required; software validation and product release experience a plus. 
  • Knowledge or experience with quality audits is preferred. 
  • Knowledge of medical manufacturing, specifically related to ISO 13485, is desired. 
  • Experience with CNC, laser welding, analyzing surface processes is preferred 
  • Experience with Spine products is a plus. 
  • Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred. 
  • ASQ Certification or equivalent is preferred but not mandatory 

Term & Start 

  • 6 month initial engagement with possible 6 mo extension. 
  • Start ASAP 
  • Onsite in Palm Beach Gardens, FL

Job Summary

JOB TYPE

Contractor

INDUSTRY

Business Services

POST DATE

09/01/2022

EXPIRATION DATE

12/15/2022

WEBSITE

gforcelifesciences.com

HEADQUARTERS

Chicago, IL

SIZE

25 - 50

INDUSTRY

Business Services

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The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.