Manager Quality Assurance Position Available In Mecklenburg, North Carolina

Manager Quality Assurance
Charlotte, NC, United States

BE THE FIRST TO APPLY JOB DESCRIPTION

Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility. He/She maintains responsibility for all aspects connected with compliance, including the development, analysis and reporting of support data for regulatory agencies and Corporate Quality. In addition, he/she is responsible for addressing all quality issues in a timely fashion and communicating that information to the site as required. The Quality Assurance Manager is responsible to assure compliance with all corporate and government procedures and regulations and serves as the Management Representative and Responsible Engineering Manager for the facility. Responsibilities Quality, Regulatory & Safety
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. Operations 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. Human Resources 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.

SUPERVISION GIVEN

May supervise the work of others. 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.
Excellent written and verbal communication skills.
Above average computer skills. Training Required Must complete all required training for a “Quality Assurance Manager” outlined in the training manual. Benefits 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) All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics

U.S. LLC

takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply. VEVRAA Federal Contractor

JOB INFO

Job Identification
13261
Job Category
Quality Assurance/Quality Control
Posting Date
04/25/2025, 08:54 AM
Locations 10811 Withers Cove Park Dr, Charlotte, NC, 28278, US
Degree Level
Bachelor’s Degree
Job Schedule
Full time