Quality Manager

1970-01-01Davis Companieshttp://www.daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Quality Manager

  • Specialty:

    • City:

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    • 55420
  • Assignment Type:

    Direct Hire
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DAVIS Companies has partnered with a leader in Medical Device manufacturing, to identify a Quality Manager for their growing team! 

Responsible for establishing a US quality system and team that promotes customer satisfaction and product quality.  Champion continuous improvement efforts and defect reduction initiatives to establish an effective Quality Management System (QMS); initiate and implement quality improvement activities as appropriate. Establish/support Quality processes and systems compliant to FDA regulations and ISO requirements related to the sale, manufacture, service and distribution of the devices. 

Essential Functions of the Quality Manager: 

  • Develop and maintain quality system related procedures according to FDA regulations and ISO requirements
  • Ensure compliance with regulatory agencies and governing bodies including FDA, ISO, notified body, etc.
  • Manage and execute internal audit program
  • Support continuous improvement efforts
  • Work collaboratively with multiple North American sales organizations and global quality organization
  • Develop/maintain quality planning methods for all product lines including data analysis
  • Design, implement, and document procedures for process control, and process improvement. 
  • Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions
  • Support engineering efforts to ensure compliance to procedures and regulatory requirements
  • Prepare management reports from quality data, which includes overall quality system performance; provide insight and recommendations for improvement
  • Provide budget inputs during annual budget reviews
  • New product introduction liaison for the Quality Department
  • Manage customer complaint/feedback process and escalate potential reportable cases to CQ
  • Manage incoming inspection, FAI, QIPs and the workload of quality inspectors
  • Manage NCRs and collaborate with Planning and SQM to resolve supplier issues
  • Support the business (our customers) in problem solving/corrective action activities related to CAPAs and ensure timelines are met
  • Support manufacturing to ensure product quality standards are met
  • Responsible for review and approval of change orders (ECO, MCO, RCO)

Competencies of the Quality Manager: 

  • Develop and promote the right behaviors and core values
  • Ability to make decisions independently
  • Provide coaching and feedback to members of the team, according to the core values of the organization
  • Excellent organizational, leadership, and analytical skills
  • Experience designing and implementing quality systems
  • Excellent problem-solving skills
  • Strong background in statistical quality methods
  • FDA and ISO 13485 regulation and standards knowledge

Required Education of the Quality Manager:

Bachelor’s Degree

Preferred Education of the Quality Manager:

Master’s Degree

Experience Required for the Quality Manager:

  • 5+ years of practical Medical Device Quality Experience supporting all elements of Quality Management System development, maintenance and improvement
  • 3-5 years of leadership experience 
  • Experience in auditing to medical device standards (ISO 13485) and regulations (FDA QSR) – Certified Lead Auditor, preferred
  • Quality Management System experience including FDA, ISO, Health Canada, and audits, preferred



Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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