Principal Quality Control Engineer

Recor Medical-posted 5 months ago
$172,175 - $186,300/Yr
Full-time • Senior
Palo Alto, CA
11-50 employees
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The Principal Quality Control Engineer is responsible for ensuring adherence to Good Manufacturing Practices (GMP) in all the manufacturing work cells and Good Laboratory Practices (GLP) in all the manufacturing and Quality Control laboratories. It will include applying tactical skills in a collaborative environment with cross-functional departments. This role involves ensuring compliance with quality and regulatory requirements.

  • Supports development of the Inspection process, validation of the Inspection equipment, works in conjunction with R&D and manufacturing to inspect and analyze new materials from suppliers, improves current inspection process.
  • Ability to lead NCMR RCA, Investigation, Correction, Corrective Action in conjunction with the cross functional team such as Operations, R&D and RA.
  • Proactively identify and assess areas for continuous quality improvements in Incoming quality, In-process quality and Final quality inspection.
  • Ability to review Validation protocols/reports, interpret and assist in statistical analysis of inspection/test data using JMP.
  • Assists in collecting and trending NCMR Data for Biweekly/Monthly/Quarterly.
  • Assist in Equipment event investigations in conjunction with Operations/R&D cross functional teams.
  • Ensures QC equipment is qualified (IQ/OQ/PQ), calibrated and maintained.
  • Ability to run MRB meetings, write minutes and follow- up with NCMR owners in a timely fashion.
  • Supports internal and external audits as the subject matter expert of the Quality Control/ Final Quality Control Areas with in-depth understanding of the manufacturing processes.
  • Responsible for the training and development of Quality Control personnel/ Junior Engineers.
  • Ability to multi-task/ attention to detail and understanding of risk-based approaches to problem solving.
  • Other essential duties as directed.
  • Bachelor of Science degree in scientific discipline or engineering.
  • Minimum of 12 + years of quality experience, in Bio-medical device industry (Preferably Class III/Class II) related to manufacturing operations, quality control, and quality engineering.
  • Working knowledge of GMP requirements and regulations: FDA CFR, ISO 13485 and other applicable industry standards.
  • Knowledge of Standard Operating Procedures and Quality Control requirements in a GMP setting.
  • Experience in writing SOPs and demonstrated ability to develop and monitor quality improvement plans and SOPs.
  • Experience with qualifications, technology and method transfer, and validation/verification of analytical methods.
  • Experience using root cause analysis tools such as Ishikawa (fishbone) diagram, fault tree, Contradiction matrix, 5Whys.
  • Experience in collecting and reviewing data to perform trend analysis.
  • Ability to work independently, self-motivated, and sense of urgency to drive for results.
  • Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
  • Excellent verbal and written communication skills and comfortable presenting to small and large groups.
  • Expertise in Statistical software such as JMP, Minitab etc.
  • CQE certified Quality Engineer is a Plus.
  • Six Sigma Black/Green Belt is a plus.
  • Expertise in Excel, Power Point, Visio, and Word.
  • Salary range: $172,175 - $186,300 (Annual Base Salary).
  • The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions.
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