The facility needs a Quality Assurance (QA) Manager to oversee and manage all quality functions, ensuring compliance with regulatory requirements and corporate standards. This role is crucial for maintaining product quality, addressing non-conformances, and driving continuous improvement within the facility.
Requirements
- 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
- Maintaining compliance with all regulatory requirements to include: FDA, OSHA, EPA, USDA and NRC as applicable.
- Coordinating activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining.
- Initiating and/or overseeing change control process.
- Analysis of facility data for identification of trends and initiation of required actions.
- Coordinating all activities relevant to FDA, ISO, customer, Internal & other regulatory audits.
- Conducting internal compliance audits as required and maintaining appropriate records.
- Coordinating/executing process validations and calibrations where required.
Other
- 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.
- 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.
- Minimum BA or BS in a related field
- Excellent written and verbal communication skills.
- Must complete all required training for a “Quality Assurance Manager” outlined in the training manual.
