Quality Assurance Manager

About the Company

Sotera Health, inspired by Soteria, the Greek goddess of safety, reflects the company’s unwavering commitment to its mission, Safeguarding Global Health®. As a leading global provider of mission-critical sterilization, lab testing, and advisory services for the healthcare industry, Sotera Health combines nearly 200 years of industry-recognized scientific and technological expertise. With 64 facilities worldwide and over 3,000 employees, the company ensures the safety of millions of patients and healthcare practitioners annually. Sotera Health serves more than 5,800 customers in over 50 countries, including over 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

About the Role

The Quality Assurance (QA) Manager reports to the General Manager and is responsible for managing and coordinating all quality functions for the facility. This role ensures compliance with corporate and government procedures and regulations, serving as the Management Representative and Responsible Engineering Manager. The QA Manager addresses quality issues, communicates compliance requirements, and drives continuous improvement.

Responsibilities

• Quality, Regulatory & Safety
  • Maintains compliance with regulatory requirements, including FDA, OSHA, EPA, USDA, and NRC.
  • Pursues continuous process and quality improvement as measured by internal indices and external audits.
  • Coordinates activities to determine and report causes of non-conformances, implements corrective actions, and assists in retraining.
  • Initiates and oversees the change control process.
  • Analyzes facility data to identify trends and initiate required actions.
  • Coordinates activities for FDA, ISO, customer, internal, and other regulatory audits.
  • Conducts internal compliance audits and maintains appropriate records.
  • Maintains facility quality records and procedures.
  • Coordinates and maintains personnel dosimetry records.
  • Coordinates system requalification activities with plant Operations.
  • Assists Corporate Quality Assurance with special projects and assignments.
  • Coordinates facility management reviews and maintains facility risk analysis.
  • Coordinates environmental monitoring and maintains personnel badge testing records.
  • Executes Equivalency and Retrospective Revalidation studies/reports where applicable.
• Operations
  • Coordinates and executes process validations and calibrations where required.
  • Reviews and releases batch records for processed materials.
  • Assists in establishing departmental objectives to meet overall facility goals.
• Human Resources
  • Communicates the company quality policy and values, motivating employees to understand the critical nature of the service.
  • Involved in hiring, retention, motivation, and development of qualified personnel in QA/Validations positions, if applicable.
  • Assists with new employee orientation, job function, GMP, safety, and developmental training.
  • Interacts with all functions within the plant.
  • Provides subordinates with clear and measurable objectives.
  • Maintains all quality-related training programs.
  • Assists with other tasks as assigned by the Supervisor.

Supervision Given: May supervise the work of others.

Requirements

• Minimum BA or BS in a related field.
• Three (3) to five (5) years of quality assurance experience in the medical services/products area or extensive quality science training (e.g., ASQ) with proven leadership potential.
• Comparable experience in the food industry is desirable for food irradiation facilities.
• Excellent written and verbal communication skills.
• Above-average computer skills.

Special Requirements

• Must be medically approved for respirator use.
• Must be able to tolerate exposure to high temperature and high humidity (120°F and 60% RH for 20 minutes).

Training Required

Must complete all required training for a “Quality Assurance Manager” outlined in the training manual.

Benefits

• Medical, Rx, Dental, Vision, Disability, and Life Insurance.
• Health Savings and Flexible Spending Accounts.
• 401(k) program with immediate Company match vesting.
• Paid holidays, vacation, and sick time.
• Free financial planning assistance.
• Paid parental leave.
• Education assistance.
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity, and Pet Insurance.
• Employee Assistance Program (EAP).