Quality Lead

3 weeks ago

Metuchen, United States ClinLab Staffing Full time

Quality Lead


Summary:


The position is responsible for the implementation and execution of the Quality program for all products, raw materials, processes, and services at the specified location. This position will work closely with all areas of the company, primarily Product Management, Purchasing, Operations, Sales and Customer Support. In addition, this position works closely on the front line with our customers, as well as with contract manufacturers and third-party vendors to ensure that our outstanding quality standards and costing initiatives are upheld.


Key Responsibilities:


  • Provide leadership for the Quality Control Program to ensure all products, raw materials, processes and services meet the Company’s exceptionally high-quality standards
  • Establish and communicate quality metrics and data to department managers for problem identification, resolution, loss reporting
  • Develop and lead the implementation and maintenance of the ISO 9001 certification plan
  • Ensure compliance with national and international standards and legislation
  • Work with the appropriate teams to ensure proper action is taken and that the steps are initiated to avoid repeat errors.
  • Work with manufacturing to design and develop quality documentation, i.e. procedures, work instructions, inspection and sampling plans, as needed or requested
  • Work with manufacturing to maintain documentation and revision level of quality documentation for all products or services
  • Lead regular quality meetings with the leadership team and other key stakeholders
  • Review non-conformities (NCRs) for determining root cause, creating corrective actions, providing customer follow up and close NCRs within an acceptable timeframe
  • Utilize analysis tools for effective corrective action and root cause investigations
  • Performs other duties as assigned.


Education:


Bachelor’s degree from an accredited higher learning institution in a related field or equivalent work experience.


Experience:


Minimum of 3 years preferred experience related to quality assurance in an ISO9001 environment, lean manufacturing, regulatory compliance in a manufacturing environment; previous direct leadership experience preferred.


Minimum Requirements/Qualifications:


  • ISO9001 auditing experience and / or auditor training would be an asset
  • Hands-on approach to troubleshoot and resolve quality related issues
  • Detail and Quality focused with strong organization, persuasion, and negotiation skills
  • Ability to present information and respond to questions from various levels within the organization
  • Proficient in the use of MS Office
  • Thrives in a fast-paced, collaborative environment, efficiently works under pressures, within deadlines or other time essential constraints.
  • Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.
  • Strong work ethic and an ability to excel within a rapidly changing and growing organization.

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