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Manager, Metrology

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

Manage Preventative Maintenance/Calibration/Repair Program

  • Prepare, maintain, and follow procedures for the calibration and metrology systems and associated processes to adhere to cGMP’s, company, local and state requirements. 
  • Maintain, review and communicate metrics to all levels of the organization.
  • Support efforts to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
  • Coordinate shutdown activities and scheduling of calibration work.
  • Develop, conduct and document test methods for instrument systems troubleshooting
  • Review Calibration Paperwork.
  • Evaluate breakdown and calibration statistics and adjust plans to suit.
  • Monitor calibration operations and implement corrective actions for out of specification results.
  • Increase overall instrument performance through optimization of calibration activities.
  • Monitor instrument calibration results and implement corrective actions for out of specification conditions.
  • Optimize spare parts stocking program for instruments
  • Assess staffing levels against requirements and production needs.
  • Support Quality Assurance investigations of calibration failures.
  • Coordinate instrument breakdown repair activities and serve as customer point of contact.
  • Facilitate completion of change control documentation.
  • Ensure that calibration files are maintained.
  • Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
  • Serve as site owner and subject matter expert of Work Order system.
  • Serve as subject matter expert on the Calibration systems
  • Prepare and manage shutdown schedules.
  • Develop and implement improvements through cross-functional interactions.
  • Develop, review, revise, and maintain SOPs for all Metrology/Calibration processes.
  • Ensures compliance with environmental regulations and works to reduce physical hazards in the facility by performing duties personally or through subordinates
  • Assist with EHS activities when applicable and appropriate.

Supervise Calibration Technicians

  • Provide day to day supervision including oversight of work quality.
  • Manage staffing levels to ensure coverage of manufacturing and lab operations.
  • Develop training and evaluate personnel.
  • Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
  • Remain current on industry and FDA engineering standards and trends.

Coordinate Service Providers

  • Manage contracts to ensure appropriate service levels at acceptable cost levels.
  • Establish agreements to assure coverage of critical systems.
  • Oversee technical quality of work performed.
  • Ensure that work performed by service providers meets regulatory expectations.

Coordinate Handover of Equipment from Engineering

  • Work with engineering team to review specifications and provide input
  • Accept turnover packages and establish maintenance programs.

Secondary Responsibilities and Functions:

  • Excellent leadership skills with the ability to work with multiple teams
  • Ability to navigate through ambiguity and rapid growth and adapt to change
  • Adapts departmental plans and priorities to address resource and operational challenges
  • Outstanding communication skills (verbal and written) to collaborate with Senior Management in a dynamic environment
  • Natural ability to be organized in how you think, communicate, and conduct your work
  • Proven ability to quickly formulate and communicate concise, logical, fact-based information and make recommendations to internal and external stakeholders

Education/Training:

  • AS or BS in a technical discipline (or equivalent experience)

Experience:

  • 10+ years of calibration experience

Skills/Abilities:

  • 7+ years of industry experience in managing regulated facilities, maintenance and calibration personnel
  • Solid background in facilities and project management

 

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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