Sterigenics · 19 hours ago
Manager Quality Assurance
SLC Metro Area
Full-time
Onsite
Mid Level
3+ years expSterigenics is a leading global provider of outsourced terminal sterilization services for the medical device, pharmaceutical, and food safety industries. They are seeking a Quality Assurance Manager who will be responsible for managing and coordinating all quality functions for the facility, ensuring compliance with regulatory requirements and addressing quality issues promptly.
Health CareMedicalMedical DevicePharmaceuticalProduct ResearchTechnical Support
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
Coordinates 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
Analysis of facility data for identification of trends and initiation of required actions
Coordinates 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
Coordinates and maintains personnel dosimetry records
Coordinates with plant Operations all system requalification activities as applicable
Assists Corporate Quality Assurance with special projects and assignments as requested
Coordinates facility management reviews
Coordinates and maintains facility risk analysis
Coordinates environmental monitoring and maintains personnel badge testing records
Executes Equivalency and Retrospective Revalidation studies/report where applicable
Coordinates/executes 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
Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service
Involved 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
Qualification
Required
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
Excellent written and verbal communication skills
Above average computer skills
Must be medically approved for respirator use (EO)
Must be able to tolerate exposure to high temperature and high humidity (120F and 60% RH for 20 minutes) (EO)
Must complete all required training for a 'Quality Assurance Manager' outlined in the training manual
Preferred
Comparable experience in the food industry is desirable (in lieu of medical experience) for food irradiation facilities
Benefits
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)
Company
Sterigenics
Sterigenics, a Sotera Health company, is a global leader in comprehensive sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets.
1001-5000 employees
H1B Sponsorship
Sterigenics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$307M2025-09-03Post Ipo Secondary· $307M
2020-11-20IPO
2011-03-23Acquired
Leadership Team
Kamila Sarraf
Human Resources Business Partner
Recent News
Chicago Tribune
2024-04-08
Company data provided by crunchbase