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Quality Specialist

Company: Distinctive Plastics, Inc.
Location: Vista
Posted on: May 10, 2022

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:

Keywords: Distinctive Plastics, Inc., Vista , Quality Specialist, Other , Vista, California

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