Distribution Manager, Quality Assurance

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Job Details

The Distribution Manager oversees the quality function of Distribution in Clinton, PA (onsite). Ensures adherence to and compliance with established company quality policies, practices, SOP’s and federal regulations. Ensures quality of materials distributed by the company. May be responsible for on-site training. Responsible for effective implementation and maintenance of Quality Systems and compliance programs in accordance with MDR/IVDR, MDD 93/42/EEC, ISO 13485, CMDR, MDSAP with additional country -specific requirements and applicable QSRs (21 CFR820, 210, 211)

May be responsible for multiple Quality Systems functions including CAPA, Complaints, NCE, Production and Process Controls 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.

Essential Duties

• Working through individual contributors or supervisors, ensures the effective implementation and maintenance for Quality Systems requirements including but not limited to, MDR/IVDR, MDD 93/42/EEC, ISO 13485, CMDR, MDSAP with additional country -specific requirements and applicable QSRs. Ensures organizational compliance with Quality Systems procedures and regulations.
• Regularly monitors the status of NCEs, and corrective actions/preventive actions to ensure quality issues are resolved and products are distributed in compliance with written specifications.
• 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.
  
  

If applicable, act as local Management Representative for Distribution having responsibility and authority at the local level that includes:

• ensuring that processes needed for the quality management system are established, implemented, and maintained,
• reporting to top management on the performance of the quality management system and any need for improvement, and
• ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
• Represents Haemonetics in 2nd (e.g. customer, contractor) and 3rd (e.g. FDA, ISO) party quality system audits.
• Partners with plant management to integrate design and engineering change to processes and product through a quality plan including verification and validation.
• Promotes and educates personnel on quality system requirements, responsibility, and accountability. Interacts with senior management and collaborates across functions, and Is subject matter expert (Haemonetics QMS)
  
  

Qualifications

• Bachelors Degree - Engineering, related scientific field, or related business – Required
• 5 years: Related experience and/or training - Required
  
  

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