Quality & Regulatory Manager

Quality & Regulatory Manager

Speciality: Engineering, View All Jobs

Location: Dover, NH, USA

Type: Full Time

Posted: 01-20-2021

Job Description

Leddy Group

Quality and/or Regulatory Manager

Leddy Group is recruiting for an experienced Quality and/or Regulatory Manager for a medical device client on New Hampshire’s Seacoast. In this role, you will work in close collaboration with other departments to solve interdisciplinary problems. You will also provide quality engineering management and leadership, ensuring compliance with OSHA, FDA, ISO, and other relevant standards.

Responsibilities of the Quality and/or Regulatory Manager

  • Develop, establish, and maintain quality programs, policies, processes, procedures and controls
  • Provide quality systems guidance, training, management and leadership to organization
  • Establish, document and implement effective process control and monitoring systems
  • Manage quality audits and analyze findings, recommending modifications in products or standards
  • Identify opportunities and lead the implementation for system compliance improvement
  • Identify quality initiatives and lead cross-functional teams to complete them
  • Utilize Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance
  • Maintains effective quality metrics and define and execute activities to resolve decreases in performance
  • Ensure continuous improvement with suppliers, components, raw materials, packaging, work-in process (WIP), finished product and equipment
  • Supervise and manage subordinate reports as assigned
  • Other quality control and management duties, as required

Qualifications of the Quality and/or Regulatory Manager

  • Bachelor’s degree in engineering or related field
  • Minimum of 7 years of experience in quality, preferably in medical device manufacturing
  • Knowledge of sterility requirements
  • Six Sigma Black Belt and ASQ Certified
  • Superior leadership and management skills
  • Excellent interpersonal and communication skills

This direct-hire, first shift Quality, and/or Regulatory Manager position is your opportunity to enhance your career in medical device quality!

To apply, email an MS Word copy of your resume to kpalmer@leddygroup.com, see our website at www.leddygroup.com or call 603-766-2004.  

About Leddy Group

We are Leddy Group . . . a privately owned, regional staffing company serving NH, ME, VT & northern MA since 1994. We are one great brand with multiple specialties:  accounting & finance, administrative & office support, engineering, human resources, industrial, skilled manufacturing, legal, and nonprofit.

At Leddy Group, we combine a consistency of values and traits with a singular standard for quality and best practices. We hold each other accountable to those standards, measure success by the quality of our outcomes, and establish goals based on continuous improvement metrics. We utilize a methodology and process to assess skills and experience; however, identifying the right “fit” is equally important for both candidates and clients alike. Our goal is to exceed your expectations. Our success is tied directly to your satisfaction.