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Senior Manager (Quality Assurance)

Leetsdale, Pennsylvania 15056 | Direct Placement

Post Date: 03/15/2018 Job ID: 75430 Category: Quality Engineers

Chat with a recruiter about this opportunity! - https://flashrecruit.com/jobs/298934

Responsible for effective implementation and maintenance of Quality Systems and compliance programs in accordance with MDD 93/42/EEC, ISO 13485, CMDR, and applicable QSRs (21 CFR820, 210, 211).

Responsible for multiple Quality Systems functions including CAPA, Complaints, Environmental Programs, Sterilization, local management review, change and design review, and all aspects of manufacturing support for processes and products, including but not limited to incoming and in-process inspection, and finished goods for a specific facility or product type/family. 

Principal Responsibilities:

As local management representative having responsibility and authority at the local level that includes:
  • Contributes to defining strategic direction for function, facility, and corporation.
  • Ensures that processes needed for the quality management system are established, implemented, and maintained.
  • Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
  • Establishes and manages inspection, sampling and testing to assure batches/products meet specification from raw material to finished goods.
  • Executes short and long term strategies of Quality Management System (QMS) and facility.
  • Interacts with senior management and collaborates across functions.
  • Oversees the quality system compliance of the site through internal audit program, local management review, quality meetings, and routine trend analysis of key performance indicators. Initiates corrective and preventive actions as required.
  • Partners with plant management to integrate design and engineering change to processes and product through a quality plan including verification and validation.
  • Partners with Plant Management to pro-actively identify and resolve quality issues and ensures products are manufactured in compliance with written specifications.
  • Regularly monitors the status of corrective actions/preventive actions to ensure quality issues are resolved and products are manufactured in compliance with written specifications.
  • Promotes and educates personnel on quality system requirements, responsibility, and accountability.
  • Reports to top management on the performance of the quality management system and any need for improvement.
  • Represents company  in 2nd (e.g. customer, contractor) and 3rd (e.g. FDA, ISO) party quality system audits.
  • Works through individual contributors or supervisors, ensures the effective implementation and maintenance for Quality Systems requirements including, but not limited to, MDD 93/42/EEC, ISO13485, CMDR, and QSRs.
  • Ensures organizational compliance with Quality Systems procedures and regulations.

Qualifications:
  • Required Bachelor' s Degree.
  • Preferred Bachelor' s Degree Engineering, Sciences, and Business.
  • Required 5 plus years related quality assurance experience FDA & ISO environment.
  • Strong Regulatory experience. 
  • Related quality assurance experience.

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