Quality Assurance Technician

Sotera Health Company; Bridgeport (CT); On-site; USD 46,000 - 72,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid holidays

Vacation and sick time

Education assistance

Parental leave

Health savings and flexible spending

Job summary

Sotera Health Company is seeking a Quality Assurance Technician in Connecticut to support the QA Manager and Validation Coordinator in maintaining the quality system and driving improvements. The role interfaces with Customer Service, Sales, Operations, Engineering and regulatory staff to ensure compliance and data-driven decision making.

Responsibilities include batch review, calibration assistance, audits, and release of production runs in MIS.

Qualifications

• High School Diploma or GED is required.
• 1 to 1.5 years of experience in a sterilization environment preferred.
• Must read, write and speak fluent English.
• Proficient computer use and ability to analyze data in a database/spreadsheet.
• Willingness to work established shifts.
• Ability to lift a minimum of 50 pounds and perform repetitive lifting.

Responsibilities

• Performs the batch review and approval.
• Performs density studies on customer products and completes tote loading diagrams.
• Assists in instrument calibration for safety and dosimetry systems and QC procedures.
• Supports scheduled quality audits and customer product inspections as needed.
• Provides backup support for the QA Manager in various functions.
• Reviews and releases production runs in the MIS system.
• Maintains Customer Master Files and training records.
• Conducts housekeeping audits according to procedures.
• Assists with other tasks assigned by Supervisor.

Skills

Quality assurance

Data analysis

English proficiency

Education

High School Diploma or GED

Tools

MIS system

Job description

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Reporting to the Quality Assurance (QA) Manager, the Quality Assurance (QA) Technician is responsible for assisting the Plant QA Manager and Validation Coordinator (if applicable) in ensuring the quality system requirements are met and maintained. This role assists in providing management with information and data on all key aspects of the day-to-day operation, which is used by both plant and corporate management to determine if the quality system is adequate and operating as designed. This information and data is also used to provide guidance for corrective actions and continuous improvement. The QA Technician must effectively interface with Customer Service, Sales, Operations, Engineering and other plant and corporate staff, as well as customers and regulatory personnel.

Responsibilities: Quality, Regulatory, & Safety

• Performs the batch review and approval.
• Performs density studies on customer products and complete applicable tote loading diagrams.
• Assists the QA Manager in calibration of instruments used in safety and dosimetry systems and performance of quality control procedures.
• Assists the QA Manager in scheduled quality audits and “as needed” customer product inspections.
• Provides backup support for the QA Manager in a variety of functions.
• Reviews and release of production run in MIS system.
• Maintains Customer Master Files & Training records.
• Conducts Housekeeping audits in accordance with written procedures.
• Assists with other tasks assigned by Supervisor.

Qualifications

• High School Diploma or GED.
• One (1) to 1.5 years of experience working in a sterilization environment preferred.
• Must be able to read, write and speak fluent English.
• Should be proficient using a computer and be able to analyze data in a database/spreadsheet.
• Must be willing to work established shifts.
• Must be able to lift a minimum of 50 pounds and perform repetitive bending and lifting motions over a period of time.

Training Required

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

Benefits/Pay

Pay Rate: $46,000–$72,000 annually, based on experience. Compensation is paid at an hourly rate

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

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.