Quality Assurance Manager

Posted 2 months ago

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

When you are part of the Madison, WI-based Phoenix team, you will be a part of a team doing important work like helping our customers to:

  • Manufacture medical radioisotopes to support the treatment of thousands of patients that need it each day
  • Non-destructively test turbine blades before they are assembled into jet engines
  • Verify the quality of nuclear fuel rods prior to shipment to power plants
  • Identify and locate buried explosive devices and concealed narcotics
  • Develop cutting-edge particle accelerator technologies supporting clean fusion energy
  • Many other developing market verticals leveraging Phoenix’s core neutron generation technology

Position Overview:

The Manager of Quality Assurance ensures that the company operates according to its quality system to provide products that meet customer requirements and maintains compliance with applicable regulations. This person is responsible for the establishment and maintenance of technical processes, procedures and work instructions, and administration in the implementation and maintenance of the quality management system processes such as ISO 9001-2015, AS9100, and others as required.

Duties and Responsibilities:

  • The QA Manager establishes, maintains and updates quality systems policies and procedures of the company to ensure that products and processes meet applicable standards and specifications
  • Manages the company quality system and acts as the Management Representative. Reports to Senior Management on the status of the quality system as well as any noncompliance issues that surface and ensures that corrective action is appropriately implemented. Provides Senior Management with timely communication of new regulatory agencies and new directions and publications
  • Hires, manages and reviews quality department technicians and engineers who provide guidance and support in quality improvement and the implementation of processes and controls required to meet or exceed the quality requirements
  • Develops the budgets, partnerships, and capital expenditure needs for the department
  • Responsible for the completeness of documentation for product development and release
  • Identifies and appropriately elevates product/supply risks to Senior Management and develops mitigation strategies
  • Provides Quality technical expertise in the development of validation strategy for process, test method, software, and facility qualification/validation
  • Provides Quality leadership for investigations and exception management
  • Provides Quality oversight for calibration and maintenance program
  • Serves as the chair for the Material Review Board
  • Leads efforts for FMEA process and product risk assessments
  • Provides support for commissioning, Factory Acceptance Tests, and Systems Acceptance Tests for production equipment
  • Implements processes to monitor product and process performance, compliance and reliability
  • Collects and analyzes data. Implements, conducts, and reports on process quality programs using statistical data analysis
  • Manages and maintains the company’s quality audit program and manages related corrective and preventive actions plans
  • Provides scientific and technical leadership during internal and Notified Body Inspection/Audit situations

Qualifications:

  • BS degree in engineering or commensurate experience – preferable in mechanical or electrical engineering
  • 5 -10 years’ experience in a direct Quality Assurance role – with experience both in product development and manufacturing
  • 2 or more years’ experience in a direct supervisory or leadership role with demonstrated success in motivating and effective performance management of others
  • Demonstrated experience with SAP® or other ERP business software is desirable
  • Direct experience in leading notified body audit, CAPA implementation and preparation of Management Reviews
  • Experience with Project Management principles and practice is desirable
  • Demonstrated experience in Six Sigma techniques is desirable
  • Demonstrated expertise with Microsoft® Office programs
  • Direct experience working within an ISO 9001, AS9100, and/or cGMP structured environment
  • Strong leadership and communication skills; strong decision-making skills; ability to communicate ideas, opinions and counter arguments in a proactive and professional manner
  • Excellent oral and written communication skills, with strong attention to detail and record keeping skills

Phoenix offers an exceptional benefit and compensation package in a transparent, collaborative team environment and is proud to be an Equal Employment Opportunity and Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. If this opportunity piques your interest and you feel Phoenix may be the organization for you, we look forward to hearing from you.

“Eligibility for employment is conditioned on an individual’s ability to qualify for access to information subject to U.S. Export Controls regulations (U.S. Citizen, U.S. Permanent Resident, Asylee or Refugee).  Also, an individual’s eligibility may be conditioned based upon access to information classified under the Atomic Energy Act requiring pre-employment drug test, fingerprinting, and a criminal background check.”

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