Quality Control Supervisor
Job Opportunity at AT3 Professional Staffing Solutions

Posted on Sep 11

http://www.at3staffing.com    5136233650

Location: Dayton, OH
Job Type: Full Time
Job ID: W4141596

We are in search of a Quality Supervisor for a successful, mid-sized medical device manufacturing company in the Dayton/Cincinnati OH area.  Our client offers a team environment, excellent culture, and a state of the art manufacturing facility.  The opportunity also offers a strong base salary, comprehensive benefits, and room for advancement.
 
The Quality Supervisor will manage the quality system throughout the department, plant, and company. The Quality Supervisor has the responsibility to comply with internal policies, procedures, FDA guidelines, ISO certifications, and International Standards and Regulations.

RESPONSIBILITIES:
  • The primary functions include Promote the quality system and provide assistance to ensure compliance with internal policies and procedures, FDA guidelines, and International Standards and Regulations. Ensure customer satisfaction and Interact with Customers in regards to complaint handling as required includes customer visits, site visits, etc.
  • Manage assessments of the quality systems for compliance (e.g. customers, FDA, ISO Registrars, International Health Authorities), and ensure that such assessments are conducted in accordance with established policies and procedures.
  • Management of internal and external audit planning, and resolution of internal and external audit findings.
  • Support External Audits
  • Facilitating ISE Site Management Reviews.
  • Support implementation of the Corporate Quality Manual, Directives, processes and Global Quality Improvement Plan.
  • Develop and maintain the Corrective and Preventive Action (CAPA) programs including necessary procedures, records, manuals, and inputs to the CAPA program.
  • Develop and maintain the customer complaint trending and complaint investigation processes including necessary procedures, records, and reports. Assure the timely response and closure of complaint investigations. Provide oversight of complaint records.
  • Access adverse event medical device reporting and medical device vigilance (MDR/MDV) based on complaints received.
  • Support in the implementation of Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance.
  • Support/lead the document control and records management team.
  • Lead or facilitate teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors.
  • Participate in cross functional teams designing, developing, monitoring, and implementing operational improvements.
  • Provide quality engineering support to contact manufacturers as needed and the manufacturing processes.
  • Manage, Mentor and guide the Quality Systems Team.
  • Support the Global Quality Systems team in implementing global and other changes which impact the effectiveness of the quality system.
  • Manage local implementation of the eQMS system and other validated systems which fall within the QMS system.
  • Other duties as assigned
QUALIFICATIONS: 
  • Must have ability to understand and apply statistical and business improvement tools to improve and sustain business results.
  • Ability to participate and in certain situations lead audit practices regarding regulatory, FDA, ISO and Customer audits.
  • Generate and ensure completion and accuracy of reports and documentations.
  • Root cause analysis tools and methodologies, corrective action implementation and effectiveness research and success.
  • Promote the quality system and provide assistance to ensure compliance with policies and procedures, regulatory affairs, and audit functions.
  • Collaborates with business unit to ensure customer satisfaction and interacts with customers in regards to complaint handling as required. May include customer site visits and/or audits.
  • Promote and upgrade continuous improvement initiatives.
  • Participate with supplier quality and manufacturing product quality.
  • Plan and execute projects and team activities to facilitate changes that have an impact on business results, especially as it relates to meeting and exceeding customer expectations.
  • Support and perform to maintain the company Quality Management System.
  • Ability to write training material and conduct training sessions on improvements and changes.
  • Support engineering efforts that relate to quality improvements. 
     
EDUCATION and/or EXPERIENCE: 
  • Bachelor's degree  
  • 5 years relevant experience maintaining and managing quality systems and regulatory compliance in the Medical Device Industry.
  • FDA/Medical Device Industry knowledge and experience is required
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