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Quality Assurance Manager

United States   •  Negotiable  •  Permanent, Full time


Our client is a global preclinical manufacturer of X-ray irradiators who have grown within the last two years and have plans to grow even more in the future having just secured 42k sq ft building in Madison Connecticut.

GENERAL DESCRIPTION

Responsible for the design, implementation, maintenance, and improvement of the Quality Management System (QMS) (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements.Quality manager will interface with various departments within the company on quality issues, handling external audits, and designing and installing a quality system designed to create the highest product quality in the industry.Act as ISO 9001 Management Representative.Responsible for managing departmental operations, such as quality procedure operations and calibration in production, complaint management, safety, and environmental compliance operations, throughput. Periodically review the suitability and effectiveness of the quality system with executive management. The Quality Manager reports to the CEO and will work closely with Engineering, Production and other departments as needed to ensure compliance with all applicable quality system requirements.This position is located in Madison, CT.

DUTIES and RESPONSIBILITIES

The Quality Manager is responsible for the following duties and responsibilities:

Directly responsible for the implementation and maintenance of Precisions Quality Management System;

Ensure that the organizations QMS conforms to FDA/ISO and internal requirements;

Coordinate/lead upgrades to the QMS

Implement and maintain ISO9001/FDA/GMP standards in R&D, QA and Process areas

Ensure the successful performance of the Calibration program;

Ensure measuring and monitoring equipment is properly controlled and maintained;

Participates in managing supplier relations, including supplier qualification and supplier performance evaluation. May include conducting supplier audits;

Assist, as needed, in providing data to evaluate and identify supplier performance;

Negotiate and approve Quality Agreements with Vendors and Contractors

Development and management of the organizations Internal Audit Program;

Represents the organization during all customer and third party audits, to include, but not limited to, FDA and ISO audits;

Responsible for yearly registration of Precision with FDA

Scheduling, organizing and conducting periodic Management Review meetings. These activities include regular follow-up and reporting on the status of identified action items;

Serves as the organizations Management Representative;

Manages the organizations CAPA program. This includes regular reporting of CAPA status to the management team, providing guidance as needed to CAPA owners, ensuring/facilitating effective root cause analysis, ensuring corrective or preventive actions affectively address identified root causes, and ensuring all required actions have been successfully completed;

Establish quality department objectives and goals to align with the Quality System and the companys business goals and objectives;

Identifying, analyzing and achieving KPIs. Prepare monthly KPI report utilizing data gathered from appropriate sources and processes;

Measure and analyze performance of key processes;

Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality;

Review, approve and author SOPs.. Perform training on cGMP and SOPs, and support continuous improvement.

Proactively report to management on quality issues and trends;

Maintenance of the quality manual and procedures;

REQUIREMENTS

10 years direct experience in Quality Management Systems;

Experience in medical or other regulated industry preferred;

Strong working knowledge of Quality System Regulation and ISO Standards;

FDA and ISO experience is important;

Understanding of quality system certification and ability to lead quality implementation efforts;

Excellent written and verbal communication skills;

Strong organizational skills;

Computer literate with good working knowledge of Microsoft based applications such as Word and Excel;

Ability to work independently and in a cross functional setting;

Proven management/supervisory skills;

Working knowledge of statistical techniques;

Experience with Corrective and Preventive Action activities;

Working knowledge of Root Cause Analysis and associated tools such as 5 WHY, Cause and Effect diagrams, etc.;

Experience as an ISO Internal Auditor highly desired;

Attention to detail required;

Must have the legal-permanent right to work the United States;

Ability to travel up to 15% including internationally;

EDUCATION REQUIREMENTS

  • BS degree in Science or Engineering;
  • Formal training in ISO 9001:2015, ISO 13485:2016, or similar quality management standards
  • Formal training/certification for Internal Audits/Lead Internal Audit is highly desirable.

** AN EQUAL OPPORTUNITY EMPLOYER **

  • Agency: Cpl Life Sciences
  • Contact: Sheldon Grant
  • Reference: JO-2110-477885
  • Updated: 8th October 2021
  • Expires: 5th November 2021

Cpl Life Sciences

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