Senior Validation Quality Engineer

Dallas, TX, US
Posted 1 weeks ago by FPC Hilton Head

Job Description

Senior Validation Quality Engineer to join our team. In this role, you will be responsible for collaborating with Quality, Manufacturing and Automation Engineering teams to validate new equipment and processes and assess changes to existing equipment and processes.

  • Support validation programs related to ISO13485 and 21 CFR Part 820 guidelines and documentation.
  • Assist in equipment design and URS.
  • Drive projects using technical expertise and knowledge of FDA's GMP regulations (QSR 820 and 210/211), and ISO 13485.
  • Create & maintain Master Validation Plans (MVP).
  • Review processes and equipment and develop validation strategies.
  • Write, review and approve IQ, OQ and PQ protocols for manufacturing processes, systems, and equipment.
  • Write, review, and approve completion reports related to IQ, OQ, and PQ protocols.
  • Lead root cause investigations relating to validation and qualification activities.
  • Approve protocols and reports through document control.
  • Write, review, and approve test method validations (TMVs) protocols and completion report.
  • Ensure ongoing compliance with quality management system.
  • Knowledge of various manufacturing processes.
  • Interface with suppliers, partners, contract manufacturers on a regular basis, including supplier and contract manufacturer qualification.
  • Ability to assist in on-site testing and validation runs.
  • Ability to travel 25%-50% of the time.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

  • Minimum 5 years of related experience in Quality Engineering, Manufacturing Engineering, and/or Validation Engineering in a regulated industry such as medical device or pharmaceutical.
  • Thorough knowledge of FDA regulations, especially 21 CFR Part 820 and ISO 13485.
  • Technical writing proficiency (e.g., protocols, analytical reports, DCOs, SOPs, Test Methods, procedures)
  • Working knowledge of risk management (pFMEAs), SPC, Capability Analysis, Gage R&R, Attribute Agreement Analysis, DOE, and other quality engineering tools such as statistical data analysis, and inspection techniques.
  • Solid problem analysis and decision-making ability and leadership skills
  • Computer literacy with Microsoft Professional Office Suite and/or Google Productivity pack and statistical software such as Minitab or JMP.
  • Excellent verbal and written communication skills
  • Strong organizational skills along with attention to detail
  • Ability to work both independently and collaboratively with small, cross-functional teams
  • Experience with high volume automation equipment is preferred

EDUCATION:

Bachelor's degree in Engineering or Applied Science

Recruiters Details

Location:
Dallas, TX, US
Job number:
J56734-HTHD
Recruiter:
David Ducharme
Office:
Hilton Head
Posted At:
1 weeks ago
Relocation:
Yes
Job Function:
Validation Engineering
Industry:
Consumer Goods, Medical Devices & Diagnostics
Education:
BA, BS