Quality Specialist
Company: Distinctive Plastics, Inc.
Location: Vista
Posted on: May 10, 2022
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Job Description:
JOB DUTIES: Utilizes knowledge of manufacturing procedures,
processes and theory to identify and resolve training/knowledge
issues, enhance training program and improve training
effectiveness. Document and investigate CAPA, CAR, Customer
Complaint. Collaborate with other various department for
development, alignment and implementation of training processes/
Corrective Action/Preventive Actions/Verification of Effectiveness
Partner with manufacturing leadership to establish training
curriculum structures and strategies. Generate and Review: Work
Order/ Travelers, Operator Work Instructions, and Standard
Operating Procedures. As well as Good Documentation Practice (GDP),
and develop content for OJTs and training runs. Assist with MRB
review, generation and disposition of NCMR. Assist with Validation
activities; IQ, OQ and PQ. Assist in gathering data and reporting
KPI metrics and trends. Drive a culture of continuous improvement
by employing Practical Process Improvement concepts and reporting
metrics and communicating internally to diverse audiences. Perform
other duties as assigned. EXPERIENCE: Minimum of 3-5 years---
experience within the Medical Device and/or Injection molding
Industry. Must have a minimum of two (2) years direct training
experience. Solid understanding of GMP guidance, including 21 CFR
Part 11, and Annex 11. Prefer hands-on industry experience in
cGMP/ISO 9001:2015/ ISO 13485:2016 regulated industries. Experience
with and knowledge of related quality systems such as Change
Control; CAPA (including: Deviations/OOSs); and Document Control is
preferred. General understanding of Six Sigma. Knowledge, Skills,
Abilities (Required): -- Knowledge of ISO 9001:2015 and ISO
13485:2016 Standards. -- Excellent communication and listening
skills. -- Ability to build and maintain strong collaborative
relationships across multiple departments. -- Microsoft office,
Power Point, and database management skills. -- Position requires
knowledge of Good Manufacturing Practices (GMP) and ISO/ industry
standards. Our Benefits: Medical & Dental paid 100% for Employee
only -- Personal Time Off. -- Holidays. -- 401k with match. --
Quarterly Bonus. . Signing Bonus Please include Phone Number and or
Email Address with your resume. Send Resume to: hrDPI-Tech.com
Keywords: Distinctive Plastics, Inc., Vista , Quality Specialist, Other , Vista, California
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