Manager Quality Assurance

Qualifications

• 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 a proven understanding of people’s motivation and proven leadership potential
• Comparable experience in the food industry is desirable (in lieu of medical experience) for food irradiation facilities
• Above average computer skills

Responsibilities

• Maintains compliance with all regulatory requirements to include: FDA, OSHA, EPA, USDA and NRC as applicable
• Actively pursues continuous process and quality improvement as measured by internal indices and external audits/reports
• Coincides activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining
• Initiates and/or oversees change control process
• Analyzes facility data for identification of trends and initiation of required actions
• Coincides all activities relevant to FDA, ISO, customer, Internal & other regulatory audits
• Conducts internal compliance audits as required and maintains appropriate records
• Maintains facility quality records and procedures
• Coincides personnel dosimetry records
• Coincides with plant Operations all system requalification activities as applicable
• Assists Corporate Quality Assurance with special projects and assignments as requested
• Coincides facility management reviews
• Coincides facility risk analysis
• Coincides environmental monitoring and maintains personnel badge testing records
• Executes Equivalency and Retrospective Revalidation studies/report where applicable
• Coincides process validations and calibrations where required
• Reviews and releases batch records for processed materials
• Assists where necessary in establishing departmental objectives to meet overall facility goals

Human Resources

• Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service
• Involves in the 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 to employees as required by Standard Operating Procedures, Certification programs, corporate requirements and customer service initiatives
• Interacts with all functions within the plant
• Provides all subordinates with clear and measurable objectives
• Maintains all quality related training programs
• Assists with other tasks as assigned by Supervisor

Pay and Benefits

Pay Rate: $92,000–$149,000 annually, based on experience.

Sotera Health Offers a Competitive Benefits Package That Includes:

• Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
• 401(k) program with Company match that immediately vests
• 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)