Job Description

Our client is an industry leader offering an awesome work culture with a great team and highly generous benefits package. If you're a leader in the Quality Control / Quality Assurance world within the FDA manufacturing industry , you'll want to apply and interview for this role!

• • Directly responsible for management of Quality Inspectors, technicians.
  • Assesses priorities and assigns work to reports to assure the project and company priorities are met
  • Participates as an active member or as team leader of teams to meet company objectives and assure department responsibilities are completed
  • Assist with the development and tracking of department and project budgets
  • Develops and implements new Standard Operating Procedures
  • Coordinates with team members and outside professionals to assure products, processes, and documentation meet users' needs as well as all applicable FDA and other regulatory agencies' requirements
  • Provides input, feedback, and maintenance on department and division procedures and policies
  • Follows and directs activities regarding safety and efficacy of products or materials and assesses impact of decisions on patient, health care provider, business, and regulations
  • Strong skills in communicating with all levels of technical and manufacturing personnel, and operating management
  • Ability to work in a cross-functional team environment, as member or leader of a cross-functional team, as well as ability to independently function in the technical and leadership areas
  • Demonstrate effective leadership capability/skills – coaching, personnel development, decision making, and Supervisory discretion
  • Analytical and mathematical skills; proficiency in Statistics, Inspection Methods, use of measuring devices, etc.
  • Ability to work with in-house and outside manufacturers and suppliers
  • Strong ability to analyze and use technical data and resources
  • Ability to evaluate/specify requirements for products, product components and assemblies, tooling and fixture

Work Experience Requirements:

• • Minimum 5 years of related experience
  • A minimum of 3-5 years of experience should be in a supervisory capacity
  • Demonstrated leadership, positive communication and human relation skills
  • Demonstrated knowledge of manufacturing and quality systems requirements for medical devices
  • Experience in international medical device registration is a plus

Education Requirements:

• • Associates or Bachelor's Degree in Technical or related area preferred

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