Quality Engineer III - Integrated Resources, Inc
Carlsbad, CA 92008
About the Job
Job Description:
A Day in the Life:
" Collaborate across functions and sites, applying quality and manufacturing expertise to solve problems, interpret data and determine next steps based on risk-based approach.
" Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs)
" Support in change control activities for documents and manufacturing processes
" Assist with regulatory, customer and internal audits
" Provide guidance and direction to ensure ISO/Quality system compliance
" Handle maintenance, completeness and accuracy of Quality records
" Perform training on Quality procedures/processes
" Create, review and review quality processes and procedures
" Collect, analyze, trend and report out on quality metrics
" Drive a culture of continuous improvement by employing Practical Process Improvement concepts.
" Support complex, multi-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software) and drives resolution and proactive solutions to customer complaints (functional defects with components or performance related failures), backorder issues, and material disposition.
" Provide knowledge and guidance on validation and stability testing activities.
" Perform other duties, as assigned.
Keys to Success:
Education
" Bachelor s degree in Science required. Preferably in Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.
Experience
" At least 3 years experience within a highly regulated field. Preferably in Medical Device or Pharmaceutical Industry supporting Regulated Products.
" Experience in GMP guidance, medical device, including 21 CFR Part 11 required.
" Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
Knowledge, Skills, Abilities
" Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
" Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.
" Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
" Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
" Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001/13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
" Quality tools e.g. Root Cause Analysis, Risk Assessment.
" Global Systems e.g. TrackWise, OCPLM, E1, LIMS
" Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (OCPLM, Trackwise, LIMS, Master Control, ERP, etc.).
Knowledge, Skills, Abilities (Preferred)
" Experience with biological manufacturing processes.
" Project Management advanced experience.
" Certified Lean Professional or Six Sigma
M-F 8am-5pm 100% on site
Comments for Suppliers: M-F 8am-5pm 100% on site
A Day in the Life:
" Collaborate across functions and sites, applying quality and manufacturing expertise to solve problems, interpret data and determine next steps based on risk-based approach.
" Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs)
" Support in change control activities for documents and manufacturing processes
" Assist with regulatory, customer and internal audits
" Provide guidance and direction to ensure ISO/Quality system compliance
" Handle maintenance, completeness and accuracy of Quality records
" Perform training on Quality procedures/processes
" Create, review and review quality processes and procedures
" Collect, analyze, trend and report out on quality metrics
" Drive a culture of continuous improvement by employing Practical Process Improvement concepts.
" Support complex, multi-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software) and drives resolution and proactive solutions to customer complaints (functional defects with components or performance related failures), backorder issues, and material disposition.
" Provide knowledge and guidance on validation and stability testing activities.
" Perform other duties, as assigned.
Keys to Success:
Education
" Bachelor s degree in Science required. Preferably in Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.
Experience
" At least 3 years experience within a highly regulated field. Preferably in Medical Device or Pharmaceutical Industry supporting Regulated Products.
" Experience in GMP guidance, medical device, including 21 CFR Part 11 required.
" Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
Knowledge, Skills, Abilities
" Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
" Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.
" Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
" Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
" Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001/13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
" Quality tools e.g. Root Cause Analysis, Risk Assessment.
" Global Systems e.g. TrackWise, OCPLM, E1, LIMS
" Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (OCPLM, Trackwise, LIMS, Master Control, ERP, etc.).
Knowledge, Skills, Abilities (Preferred)
" Experience with biological manufacturing processes.
" Project Management advanced experience.
" Certified Lean Professional or Six Sigma
M-F 8am-5pm 100% on site
Comments for Suppliers: M-F 8am-5pm 100% on site
Source : Integrated Resources, Inc